HIVHIV KAPNCT02667808
Exploring the Impact of HIV and ART on Knowledge, Attitudes and Practices in Reproductive Health in Lilongwe, Malawi
An observational study of HIV and AIDS, run by Emory University at 1 site in Malawi.
Trial summary
The aim of this study is to identify reproductive health priorities among individuals living with HIV.This study also seeks to explore factors that influence fertility, family planning, and sexual behavior among individuals with HIV who are receiving antiretroviral therapy (ART). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- Focus Group and Questionnaire
- How many people
- 562 participants
- Where
- 1 siteMalawi
- Study dates
- Aug 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Persons living with HIV in Lilongwe, Malawi recruited from The Lighthouse Trust Clinic
Who may be able to join
- Client registered at either of the participating Lighthouse clinics (Kamuzu Central Hospital (KCH) or Bwaila Hospital)
- On antiretroviral treatment (ART) for the past 6 months
- Sexually active within the past 6 months
- HIV positive
- Client registered at either of the participating Lighthouse clinics (Kamuzu Central Hospital (KCH) or Bwaila Hospital)
- Sexually active within the past 6 month
- HIV positive
Who cannot join
- No exclusion criteria specified
- Questionnaire Arm
- No exclusion criteria specified
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to identify reproductive health priorities among individuals living with HIV.This study also seeks to explore factors that influence fertility, family planning, and sexual behavior among individuals with HIV who are receiving antiretroviral therapy (ART).
Read the detailed description
The aim of this study is to identify reproductive health priorities among individuals living with HIV.This study also seeks to explore factors that influence fertility, family planning, and sexual behavior among individuals with HIV who are receiving antiretroviral therapy (ART).
This is a mixed method study in which subjects will participate in focused group discussions and complete a questionnaire. Discussions will be 1-2 hours in length aimed to evaluate fertility intentions, family planning, and sexual health behaviors. Data collected from the focus groups will be analyzed for common themes to generate questionnaires to assess reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health among persons living with HIV.
- Being tested
- Focus Group, Questionnaire
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupOther
Subjects will participate in four to eight group discussions aimed to evaluate fertility intentions, family planning, and sexual health behaviors. Discussions will be 1-2 hours in length. Groups will be conducted among men and women.
QuestionnaireOther
Participants will complete a questionnaire assessing reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health. The questionnaire will take no longer than 30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | Participants with HIV and receiving antiretroviral therapy (ART) will participate in four to eight group discussions aimed to evaluate fertility intentions, family planning, and sexual health behaviors. Discussions will be 1-2 hours in length. Groups will be conducted among men and women. Receives: Other: Focus Group | |
| Questionnaire | Participants with HIV will complete a questionnaire assessing reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health. The questionnaire will take no longer than 30 minutes to complete. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of ideal family size assessed by focus group discussion
Perception of ideal family size will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Perception of social pressures regarding fertility intentions assessed by focus group discussion
Perception of social pressures regarding fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Perception of familial pressures regarding fertility intentions assessed by focus group discussion
Perception of familial pressures regarding fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Perception of partner pressures regarding fertility intentions assessed by focus group discussion
Perception of partner pressures regarding fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Influence of human immunodeficiency virus (HIV) on fertility intentions assessed by focus group discussion
Influence of human immunodeficiency virus (HIV) on fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Influence of antiretroviral therapy (ART) on fertility intentions assessed by focus group discussion
Influence of antiretroviral therapy (ART) on fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Perception of concordance among couples on fertility intention assessed by focus group discussion
The agreement on fertility intention among couples will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Perception of how relationship status influences fertility intentions assessed by focus group discussion
The perception of how relationship status influences fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Perception of how reproductive health issues impact fertility intentions assessed by focus group discussion
Perception of how reproductive health issues impact fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Knowledge regarding family planning methods assessed by focus group discussion
Knowledge regarding family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Knowledge regarding family planning misconceptions assessed by focus group discussion
Knowledge regarding family planning misconceptions and beliefs will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Current family planning methods assessed by focus group discussion
Current family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Previously used family planning methods assessed by focus group discussion
Previously used family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Intent to use family planning methods assessed by focus group discussion
Intent to use family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Perception of social influence on family planning methods assessed by focus group discussion
Perception of social influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Perception of familial influence on family planning methods assessed by focus group discussion
Perception of familial influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Perception of partner influence on family planning methods assessed by focus group discussion
Perception of partner influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Human immunodeficiency virus (HIV) influence on family planning methods assessed by focus group discussion
Human immunodeficiency virus (HIV) influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Antiretroviral therapy (ART) use influence on family planning methods assessed by focus group discussion
Antiretroviral therapy (ART) use influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours
Measured: Discussion Visit (Day 0, Up to 2 hours)
Antiretroviral therapy (ART) non-use influence on family planning methods assessed by focus group discussion
Antiretroviral therapy (ART) non-use influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Influence of human immunodeficiency virus (HIV) on use of dual protection assessed by focus group discussion
Influence of HIV on use of dual protection will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Influence of human immunodeficiency virus (HIV) on non-use of dual protection assessed by focus group discussion
Influence of HIV on non-use of dual protection will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Influence of antiretroviral therapy (ART) on use of dual protection assessed by focus group discussion
Influence of ART on use of dual protection will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Influence of antiretroviral therapy (ART) on non-use of dual protection assessed by focus group discussion
Influence of ART on non-use of dual protection will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Perception of sexually transmitted infection (STI) risk assessed by focus group discussion
Perception of sexually transmitted infection (STI) risk will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Perception of risk of human immunodeficiency virus (HIV) transmission to partners or children assessed by focus group discussion
Perception of risk of HIV transmission to partners or children will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Measured: Discussion Visit (Day 0, Up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startAug 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Haddad, Emory University
- Investigators
- Lisa Haddad, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667808
- Sponsor's protocol ID
- IRB00051780
- Acronym
- HIV KAP
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2016
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of HIV and ART on Knowledge, Attitudes and Practices in Reproductive Health in Lilongwe, Malawi
- ClinicalTrials.gov ID
- NCT02667808
- Acronym / sponsor ID
- HIV KAP / IRB00051780
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to identify reproductive health priorities among individuals living with HIV.This study also seeks to explore factors that influence fertility, family planning, and sexual behavior among individuals with HIV who are receiving antiretroviral therapy (ART).
Detailed description
The aim of this study is to identify reproductive health priorities among individuals living with HIV.This study also seeks to explore factors that influence fertility, family planning, and sexual behavior among individuals with HIV who are receiving antiretroviral therapy (ART).
This is a mixed method study in which subjects will participate in focused group discussions and complete a questionnaire. Discussions will be 1-2 hours in length aimed to evaluate fertility intentions, family planning, and sexual health behaviors. Data collected from the focus groups will be analyzed for common themes to generate questionnaires to assess reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health among persons living with HIV.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus Group | – | Other: Focus GroupParticipants with HIV and receiving antiretroviral therapy (ART) will participate in four to eight group discussions aimed to evaluate fertility intentions, family planning, and sexual health behaviors. Discussions will be 1-2 hours in length. Groups will be conducted among men and women. |
| Questionnaire | – | Other: QuestionnaireParticipants with HIV will complete a questionnaire assessing reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health. The questionnaire will take no longer than 30 minutes to complete. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Persons living with HIV in Lilongwe, Malawi recruited from The Lighthouse Trust Clinic
Key inclusion criteria (7 listed)
- Client registered at either of the participating Lighthouse clinics (Kamuzu Central Hospital (KCH) or Bwaila Hospital)
- On antiretroviral treatment (ART) for the past 6 months
- Sexually active within the past 6 months
- HIV positive
- Client registered at either of the participating Lighthouse clinics (Kamuzu Central Hospital (KCH) or Bwaila Hospital)
Key exclusion criteria (3 listed)
- No exclusion criteria specified
- Questionnaire Arm
- No exclusion criteria specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus GroupSubjects will participate in four to eight group discussions aimed to evaluate fertility intentions, family planning, and sexual health behaviors. Discussions will be 1-2 hours in length. Groups will be conducted among men and women. | Other | Focus Group |
| QuestionnaireParticipants will complete a questionnaire assessing reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health. The questionnaire will take no longer than 30 minutes to complete. | Other | Questionnaire |
Primary outcome
Perception of ideal family size assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Perception of ideal family size will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Perception of social pressures regarding fertility intentions assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Perception of social pressures regarding fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Perception of familial pressures regarding fertility intentions assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Perception of familial pressures regarding fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Perception of partner pressures regarding fertility intentions assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Perception of partner pressures regarding fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Influence of human immunodeficiency virus (HIV) on fertility intentions assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Influence of human immunodeficiency virus (HIV) on fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Influence of antiretroviral therapy (ART) on fertility intentions assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Influence of antiretroviral therapy (ART) on fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Perception of concordance among couples on fertility intention assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
The agreement on fertility intention among couples will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Perception of how relationship status influences fertility intentions assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
The perception of how relationship status influences fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Perception of how reproductive health issues impact fertility intentions assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Perception of how reproductive health issues impact fertility intentions will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Knowledge regarding family planning methods assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Knowledge regarding family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Knowledge regarding family planning misconceptions assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Knowledge regarding family planning misconceptions and beliefs will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Current family planning methods assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Current family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Previously used family planning methods assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Previously used family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Intent to use family planning methods assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Intent to use family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Perception of social influence on family planning methods assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Perception of social influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Perception of familial influence on family planning methods assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Perception of familial influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Perception of partner influence on family planning methods assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Perception of partner influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Human immunodeficiency virus (HIV) influence on family planning methods assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Human immunodeficiency virus (HIV) influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Antiretroviral therapy (ART) use influence on family planning methods assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Antiretroviral therapy (ART) use influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours
Antiretroviral therapy (ART) non-use influence on family planning methods assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Antiretroviral therapy (ART) non-use influence on family planning methods will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Influence of human immunodeficiency virus (HIV) on use of dual protection assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Influence of HIV on use of dual protection will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Influence of human immunodeficiency virus (HIV) on non-use of dual protection assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Influence of HIV on non-use of dual protection will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Influence of antiretroviral therapy (ART) on use of dual protection assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Influence of ART on use of dual protection will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Influence of antiretroviral therapy (ART) on non-use of dual protection assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Influence of ART on non-use of dual protection will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Perception of sexually transmitted infection (STI) risk assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Perception of sexually transmitted infection (STI) risk will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Perception of risk of human immunodeficiency virus (HIV) transmission to partners or children assessed by focus group discussion
Time frame: Discussion Visit (Day 0, Up to 2 hours)
Perception of risk of HIV transmission to partners or children will be discussed in a focus group setting between 6-8 men or women. Focus groups will be facilitated by a trained member of the research team. The discussions will be audio taped and there will be a note-taker attending each group. Notes will be taken during the groups should elements of the audio recording need clarification as well as to capture non-verbal responses and communication. Focus group discussion will take between one to two hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Haddad, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and AIDS, run by Emory University at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of ideal family size assessed by focus group discussion (time frame: Discussion Visit (Day 0, Up to 2 hours)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.