HIV InfectionNCT00489034
Engaging Care for HIV-infected Adolescent Females.
An observational study of HIV Infection, run by University of North Carolina, Chapel Hill at 5 sites in United States.
Trial summary
The proposed multi-site, longitudinal study will examine the correlation of substance use, mental health disorders, and social networks to engagement in care for HIV-infected adolescent females, aged 13 years, 0 months - 23 years, 11 months, and suggest ways to promote adherence and retention in treatment, care, and… Read more about this study
- Who is it for?
- Ages 13 to 23 years, women only
- Conditions the study is for
- HIV Infection
- What is being tested?
- Quantitative Interview, Ethnographic Interview and Gender Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 178 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2003to Dec 2010
- 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 13 to 23 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: HIV-infected adolescent females, aged 13 years, 0 months - 23 years, 11 months will be followed to examine the correlation of substance use, mental health disorders, and social networks to engagement in care and suggested ways to promote adherence and retention in treatment, care, and prevention.
Who may be able to join
- Index Participants:
- Enrolled in Quantitative NIDA study.
- English-speaking at Miami, New York, Chicago, and New Orleans sites.
- English or Spanish-speaking at Los Angeles USC site
- Network Participants:
- English-speaking at Miami, New York, Chicago, and New Orleans sites.
Show all 13Show fewer
- English or Spanish-speaking at Los Angeles USC site.
- Know index serostatus.
- Gender Sub-Sample
- Age 18 years, 0 months - 23 years, 11 months.
- Enrolled in quantitative study.
- English-speaking.
- Female.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Universtiy of Southern California
Los Angeles, California, 90033
University of Miami, School of Medicine
Miami, Florida, 33101
Tulane Medical Center
New Orleans, Louisiana, 70112
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Drug Use and HIV-Infected Female Adolescents' Care Use
The proposed multi-site, longitudinal study will examine the correlation of substance use, mental health disorders, and social networks to engagement in care for HIV-infected adolescent females, aged 13 years, 0 months - 23 years, 11 months, and suggest ways to promote adherence and retention in treatment, care, and prevention programs. Qualitative and quantitative data collection methods will be used with index participants and network members.
Read the detailed description
The primary outcome examined in the proposed study is engagement in care, operationalized as the number of clinical visits attended. Clinic visits will be monitored on a weekly basis. Secondary outcomes of interest include medication adherence, sexual risk behaviors, and substance use. For the quantitative study, formal psychological testing will be conducted with index adolescent females, and biological specimens will be collected to validate self-reported drug use. CD-4 counts and viral load will be monitored every three months via chart review.
Index adolescents will be interviewed every six months (with phone interviews focused on service utilization at each six month interval midpoint) for eighteen months while network members will be interviewed at baseline and one year.
Qualitative interviews in the Ethnographic Study will be conducted with a small sub-sample of index and identified network participants from each site at least monthly for a period of at least 18 months. Qualitative interviews will be ethnographic in nature and will rely on participants' life stories and narratives of social experience to supply their content and to guide their progression.
Qualitative Interviews in the Gender Substudy will be conducted with a subsample of index participants. These qualitative interviews will focus on issues of gender related vulnerabilities and will be used to develop a survey to be administered to all index participants from sites participating in this substudy.
- Conditions
- HIV Infection
- Being tested
- Quantitative Interview, Ethnographic Interview, Gender Interview
- Keywords
- HIV, adolescent females, adherence, clinical care, risk behaviors
- Medical subject headings
- HIV Infections, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative InterviewBehavioural
Index participants will be interviewed every six months (with phone interviews focused on service utilization at each six month interval midpoint) for 18 months while network members will be interviewed at baseline and one year. Interviews will consist of in-depth face-to-face and audio computer-assisted interviews (ACASIs) and a structured diagnostic interview to assess engagement in care (number of clinical visits attended), substance use, attitudes about substance use, friend's substance use, sexual risk behaviors, PTSD (for index participants only), support of index participants care use (network participants only), attitudes about healthcare (network participants only), index participant's adherence (network participants only), own functioning (network participants only), and family functioning (network participants only). At Baseline only, a urine sample will be collected from index participants for drug testing to assess the agreement between urine and ACASI.
Ethnographic InterviewBehavioural
Qualitative interviews will be conducted with a small sub-sample of index and identified network participants from each site at least monthly for a period of 18 months. Interviews will be ethnographic in nature and will rely on participants' life stories and narratives of social experience to supply their content and guide their progression.
Gender InterviewBehavioural
Qualitative interviews will be conducted with a sub-sample of index participants. These interviews will focus on issues of gender related vulnerabilities and will be used to develop a survey.
| Study group | Role | What they receive |
|---|---|---|
| Index Participants | HIV-infected females, ages 13- 23 years, recruited from ATN sites in New York, Chicago, Miami, Los Angeles, and New Orleans will undergo quantitative interviewing. A sub-sample of the group will undergo ethnographic and/or gender interviewing. Receives: Behavioral: Quantitative Interview; Behavioral: Ethnographic Interview; Behavioral: Gender Interview | |
| Network Participants | Closest friends of index participants s and parents/guardians of index participants who know the index participant's HIV status will undergo quantitative interviewing. A sub-sample of the group will undergo ethnographic interviewing. Receives: Behavioral: Quantitative Interview; Behavioral: Ethnographic Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in Care among Index Participants
Engagement in care will be operationalized as the number of clinic visits attended and will be assessed through the qualitative interviews.
Measured: Baseline, 6 months, 12 months, and 18 months
Secondary outcomes (3)
Medication Adherence
As assessed through the qualitative interviews for index and network participants.
Measured: Baseline, 6 months, 12 months, and 18 months
Sexual Risk Behaviors
As assessed through the qualitative interviews for index and network participants.
Measured: Baseline, 6 months, 12 months, and 18 months
Substance Use
As assessed through the qualitative interviews for index and network participants.
Measured: Baseline, 6 months, 12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startJul 2003
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Lori Perez, Ph.D, Study director, Westat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489034
- Sponsor's protocol ID
- ATN 009
- Other IDs
- 1R01DA014706-01
- Status last verified
- Aug 2016
- First submitted
- 19 Jun 2007
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use and HIV-Infected Female Adolescents' Care Use
- ClinicalTrials.gov ID
- NCT00489034
- Acronym / sponsor ID
- ATN 009
- Conditions
- HIV Infection
- Keywords
- HIV, adolescent females, adherence, clinical care, risk behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2003
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Jun 2007 (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 proposed multi-site, longitudinal study will examine the correlation of substance use, mental health disorders, and social networks to engagement in care for HIV-infected adolescent females, aged 13 years, 0 months - 23 years, 11 months, and suggest ways to promote adherence and retention in treatment, care, and prevention programs. Qualitative and quantitative data collection methods will be used with index participants and network members.
Detailed description
The primary outcome examined in the proposed study is engagement in care, operationalized as the number of clinical visits attended. Clinic visits will be monitored on a weekly basis. Secondary outcomes of interest include medication adherence, sexual risk behaviors, and substance use. For the quantitative study, formal psychological testing will be conducted with index adolescent females, and biological specimens will be collected to validate self-reported drug use. CD-4 counts and viral load will be monitored every three months via chart review.
Index adolescents will be interviewed every six months (with phone interviews focused on service utilization at each six month interval midpoint) for eighteen months while network members will be interviewed at baseline and one year.
Qualitative interviews in the Ethnographic Study will be conducted with a small sub-sample of index and identified network participants from each site at least monthly for a period of at least 18 months. Qualitative interviews will be ethnographic in nature and will rely on participants' life stories and narratives of social experience to supply their content and to guide their progression.
Qualitative Interviews in the Gender Substudy will be conducted with a subsample of index participants. These qualitative interviews will focus on issues of gender related vulnerabilities and will be used to develop a survey to be administered to all index participants from sites participating in this substudy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index Participants | – | Behavioral: Quantitative Interview, Behavioral: Ethnographic Interview, Behavioral: Gender InterviewHIV-infected females, ages 13- 23 years, recruited from ATN sites in New York, Chicago, Miami, Los Angeles, and New Orleans will undergo quantitative interviewing. A sub-sample of the group will undergo ethnographic and/or gender interviewing. |
| Network Participants | – | Behavioral: Quantitative Interview, Behavioral: Ethnographic InterviewClosest friends of index participants s and parents/guardians of index participants who know the index participant's HIV status will undergo quantitative interviewing. A sub-sample of the group will undergo ethnographic interviewing. |
Who may qualify
- Ages
- 13 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- HIV-infected adolescent females, aged 13 years, 0 months - 23 years, 11 months will be followed to examine the correlation of substance use, mental health disorders, and social networks to engagement in care and suggested ways to promote adherence and retention in treatment, care, and prevention.
Key inclusion criteria (13 listed)
- Enrolled in Quantitative NIDA study.
- English-speaking at Miami, New York, Chicago, and New Orleans sites.
- English or Spanish-speaking at Los Angeles USC site
- English-speaking at Miami, New York, Chicago, and New Orleans sites.
- English or Spanish-speaking at Los Angeles USC site.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Quantitative InterviewIndex participants will be interviewed every six months (with phone interviews focused on service utilization at each six month interval midpoint) for 18 months while network members will be interviewed at baseline and one year. Interviews will consist of in-depth face-to-face and audio computer-assisted interviews (ACASIs) and a structured diagnostic interview to assess engagement in care (number of clinical visits attended), substance use, attitudes about substance use, friend's substance use, sexual risk behaviors, PTSD (for index participants only), support of index participants care use (network participants only), attitudes about healthcare (network participants only), index participant's adherence (network participants only), own functioning (network participants only), and family functioning (network participants only). At Baseline only, a urine sample will be collected from index participants for drug testing to assess the agreement between urine and ACASI. | Behavioural | Index Participants, Network Participants |
| Ethnographic InterviewQualitative interviews will be conducted with a small sub-sample of index and identified network participants from each site at least monthly for a period of 18 months. Interviews will be ethnographic in nature and will rely on participants' life stories and narratives of social experience to supply their content and guide their progression. | Behavioural | Index Participants, Network Participants |
| Gender InterviewQualitative interviews will be conducted with a sub-sample of index participants. These interviews will focus on issues of gender related vulnerabilities and will be used to develop a survey. | Behavioural | Index Participants |
Primary outcome
Engagement in Care among Index Participants
Time frame: Baseline, 6 months, 12 months, and 18 months
Engagement in care will be operationalized as the number of clinic visits attended and will be assessed through the qualitative interviews.
3 secondary outcomes
Medication Adherence
Time frame: Baseline, 6 months, 12 months, and 18 months
Sexual Risk Behaviors
Time frame: Baseline, 6 months, 12 months, and 18 months
Substance Use
Time frame: Baseline, 6 months, 12 months, and 18 months
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 6 Mar 2017.
- Adolescent Medicine Trials Network for HIV/AIDS Interventions WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lori Perez, Ph.D study director
Westat
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by University of North Carolina, Chapel Hill at 5 sites in United States.
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 13 inclusion and 0 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Engagement in Care among Index Participants (time frame: Baseline, 6 months, 12 months, and 18 months). 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 6 Mar 2017.