HIVNCT01448512
Promoting Male Involvement to Improve Prevention of Mother to Child Transmission (PMTCT) Uptake and Reduce Antenatal Infection
A study testing PartnerPlus Intervention in people with HIV and Pregnancy, run by University of Miami at 1 site in South Africa.
Trial summary
This study will evaluate the impact of combining two evidence-based interventions: a couples risk reduction intervention with an evidence based medication adherence intervention designed to enhance male participation in combination with improving medication and prevention of mother to child transmission (PMTCT)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- PartnerPlus Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 1 siteSouth Africa
- Study dates
- Sep 2010to Aug 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant women age 18 and older who have received HCT (HIC Counseling \& Testing) at the antenatal clinic (ANC),
- willing to attend PartnerPlus or prevention of mother to child transmission (PMTCT) visits with their male partners,
- male partners must also be available to participate and
- both partners must be willing to participate in the study.
- All participants will be current adult residents of Mpumalanga Province and agree to be attend four group sessions, 2 psychosocial assessments and 1 three day post-delivery assessment (maternal and infant blood sample).
Who cannot join
- Single mothers not being tested for HIV at the ANC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: University of Miami Developmental Center for AIDs Research Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal Infection
This study will evaluate the impact of combining two evidence-based interventions: a couples risk reduction intervention with an evidence based medication adherence intervention designed to enhance male participation in combination with improving medication and prevention of mother to child transmission (PMTCT) adherence in antenatal clinics (ANCs). Clinics will be randomly assigned to experimental and control conditions and effectiveness of the combined intervention to enhance PMTCT as well as reduce antenatal seroconversion by both individuals and clinics will be examined. It is hypothesized that community clinics implementing PartnerPlus will have more effective PMTCT program adherence, as measured by total participant 1) maternal and paternal ANC and PartnerPlus visits, 2) maternal and paternal human immunodeficiency virus (HIV) Counseling \& Testing (HCT) uptake, 3) maternal and infant antiretroviral (ARV) prophylaxis uptake, 4) maternal highly active antiretroviral therapy (HAART) uptake, 5) infant polymerase chain reaction (PCR) for HIV, and 5) maternal and infant HIV serostatus and that community clinics implementing PartnerPlus will have reduced sexual risk behavior, as measured by participant sexual barrier use.
Read the detailed description
This study is a group-randomized controlled trial using a 2 x 6 comparison (Clinic, Experimental, Control x Time, Baseline, Post-Intervention, Pre-delivery 32 weeks, Pre-delivery day, Delivery, Post Partum). Twelve community health centers (CHCs) in communities within the Gert Sibande and Nkangala Districts in Mpumalanga, South Africa (SA) will be randomly assigned to condition in a 1:1 ratio. Six usual care condition clinics will provide the standard of care, PMTCT; six experimental condition clinics will offer PartnerPlus to mothers completing HIV testing, regardless of serostatus, who are willing to enroll with their male partners and participate in the integrated PartnerPlus intervention. This study will recruit 240 couples (n = 480 individuals); community clinics will recruit 2 cohort per clinic over 3 months (10 couples per cohort, n = 40, 120 individuals per condition).
- Being tested
- PartnerPlus Intervention, Usual Care
- Keywords
- HIV, Pregnancy, Prevention, Couples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PartnerPlus InterventionBehavioural
Also called Cognitive behavioral risk reduction intervention
The intervention employs a closed, structured, group intervention limited to 10 participants (women or men). Four weekly, 11/2-2 hour sessions are led by a trained gender-congruent counselor and a peer facilitator and emphasize group participation, cognitive-behavioral skill building, sexual negotiation and experimentation with products.
Usual CareOther
Also called Standard of Care
4 time matched sessions focused on health education
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | Participation in 4 time matched sessions on health education topics Receives: Other: Usual Care |
| PartnerPlus intervention | Experimental | Four group counseling sessions focused on prevention of mother to child transmission (PMTCT) sexual risk reduction \& adherence. Receives: Behavioral: PartnerPlus Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of ANC visits by mother and father from baseline to one month post intervention to 32 weeks to 3 days post partum
Measured: Baseline, one month, 32 weeks, 3 days post partum
Secondary outcomes (5)
Change in Mother, father, infant HIV VCT from baseline to one month to 3 days post partum
Measured: Baseline, one month, 3 days post partum
Mother and infant ARV prophylaxis
Measured: 3 days post partum
Change in Maternal PMTCT ARV uptake from baseline to 32 weeks to 3 days post partum
Measured: Baseline, 32 weeks, 3 days post partum
Infant PCR
Measured: 6 weeks
Change in rate of condom use from baseline to one month to 3 days post partum
Measured: Baseline, one month, 3 days post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionAug 2012
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 University of MiamiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Jones, University of Miami
- Investigators
- Karl Peltzer, PhD, Study director, Human Sciences Research CouncilDeborah Jones, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448512
- Sponsor's protocol ID
- 5P30AI073961-S
- Other IDs
- P30AI073961
- Status last verified
- Jan 2014
- First submitted
- 26 Sep 2011
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Miami Developmental Center for AIDs Research Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal Infection
- ClinicalTrials.gov ID
- NCT01448512
- Acronym / sponsor ID
- 5P30AI073961-S
- Keywords
- HIV, Pregnancy, Prevention, Couples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Oct 2011 (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.
This study will evaluate the impact of combining two evidence-based interventions: a couples risk reduction intervention with an evidence based medication adherence intervention designed to enhance male participation in combination with improving medication and prevention of mother to child transmission (PMTCT) adherence in antenatal clinics (ANCs). Clinics will be randomly assigned to experimental and control conditions and effectiveness of the combined intervention to enhance PMTCT as well as reduce antenatal seroconversion by both individuals and clinics will be examined. It is hypothesized that community clinics implementing PartnerPlus will have more effective PMTCT program adherence, as measured by total participant 1) maternal and paternal ANC and PartnerPlus visits, 2) maternal and paternal human immunodeficiency virus (HIV) Counseling \& Testing (HCT) uptake, 3) maternal and infant antiretroviral (ARV) prophylaxis uptake, 4) maternal highly active antiretroviral therapy (HAART) uptake, 5) infant polymerase chain reaction (PCR) for HIV, and 5) maternal and infant HIV serostatus and that community clinics implementing PartnerPlus will have reduced sexual risk behavior, as measured by participant sexual barrier use.
Detailed description
This study is a group-randomized controlled trial using a 2 x 6 comparison (Clinic, Experimental, Control x Time, Baseline, Post-Intervention, Pre-delivery 32 weeks, Pre-delivery day, Delivery, Post Partum). Twelve community health centers (CHCs) in communities within the Gert Sibande and Nkangala Districts in Mpumalanga, South Africa (SA) will be randomly assigned to condition in a 1:1 ratio. Six usual care condition clinics will provide the standard of care, PMTCT; six experimental condition clinics will offer PartnerPlus to mothers completing HIV testing, regardless of serostatus, who are willing to enroll with their male partners and participate in the integrated PartnerPlus intervention. This study will recruit 240 couples (n = 480 individuals); community clinics will recruit 2 cohort per clinic over 3 months (10 couples per cohort, n = 40, 120 individuals per condition).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Other: Usual CareParticipation in 4 time matched sessions on health education topics |
| PartnerPlus intervention | Experimental | Behavioral: PartnerPlus InterventionFour group counseling sessions focused on prevention of mother to child transmission (PMTCT) sexual risk reduction \& adherence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pregnant women age 18 and older who have received HCT (HIC Counseling \& Testing) at the antenatal clinic (ANC),
- willing to attend PartnerPlus or prevention of mother to child transmission (PMTCT) visits with their male partners,
- male partners must also be available to participate and
- both partners must be willing to participate in the study.
- All participants will be current adult residents of Mpumalanga Province and agree to be attend four group sessions, 2 psychosocial assessments and 1 three day post-delivery assessment (maternal and infant blood sample).
Key exclusion criteria (1 listed)
- Single mothers not being tested for HIV at the ANC
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 |
|---|---|---|
| PartnerPlus InterventionAlso: Cognitive behavioral risk reduction interventionThe intervention employs a closed, structured, group intervention limited to 10 participants (women or men). Four weekly, 11/2-2 hour sessions are led by a trained gender-congruent counselor and a peer facilitator and emphasize group participation, cognitive-behavioral skill building, sexual negotiation and experimentation with products. | Behavioural | PartnerPlus intervention |
| Usual CareAlso: Standard of Care4 time matched sessions focused on health education | Other | Usual Care |
Primary outcome
Change in number of ANC visits by mother and father from baseline to one month post intervention to 32 weeks to 3 days post partum
Time frame: Baseline, one month, 32 weeks, 3 days post partum
5 secondary outcomes
Change in Mother, father, infant HIV VCT from baseline to one month to 3 days post partum
Time frame: Baseline, one month, 3 days post partum
Mother and infant ARV prophylaxis
Time frame: 3 days post partum
Change in Maternal PMTCT ARV uptake from baseline to 32 weeks to 3 days post partum
Time frame: Baseline, 32 weeks, 3 days post partum
Infant PCR
Time frame: 6 weeks
Change in rate of condom use from baseline to one month to 3 days post partum
Time frame: Baseline, one month, 3 days post partum
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 22 Jan 2014.
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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.
Karl Peltzer, PhD study director
Human Sciences Research Council
Deborah Jones, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PartnerPlus Intervention in people with HIV and Pregnancy, run by University of Miami at 1 site in South Africa.
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 5 inclusion and 1 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 22 Jan 2014. 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 South Africa. 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?
Change in number of ANC visits by mother and father from baseline to one month post intervention to 32 weeks to 3 days post partum (time frame: Baseline, one month, 32 weeks, 3 days post partum). 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 22 Jan 2014.