Promoting Male Involvement to Improve Prevention of Mother to Child Transmission (PMTCT) Uptake and Reduce Antenatal Infection

Study Overview
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Brief Summary
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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
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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).

Official Title
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University of Miami Developmental Center for AIDs Research Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal Infection

Conditions
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HIV, Pregnancy

Intervention / Treatment
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* Behavioral: PartnerPlus Intervention
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Single mothers not being tested for HIV at the ANC

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual Care<br>Participation in 4 time matched sessions on health education topics | Other: Usual Care<br>* 4 time matched sessions focused on health education<br>* Other names: Standard of Care;|
| Experimental: PartnerPlus intervention<br>Four group counseling sessions focused on prevention of mother to child transmission (PMTCT) sexual risk reduction & adherence. | Behavioral: PartnerPlus Intervention<br>* 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.<br>* Other names: Cognitive behavioral risk reduction intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Baseline, one month, 32 weeks, 3 days post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mother, father, infant HIV VCT from baseline to one month to 3 days post partum |  | Baseline, one month, 3 days post partum | 
| Mother and infant ARV prophylaxis |  | 3 days post partum | 
| Change in Maternal PMTCT ARV uptake from baseline to 32 weeks to 3 days post partum |  | Baseline, 32 weeks, 3 days post partum | 
| Infant PCR |  | 6 weeks | 
| Change in rate of condom use from baseline to one month to 3 days post partum |  | Baseline, one month, 3 days post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, HIV, Prevention, Couples