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| ID | Type | Description | Link |
|---|---|---|---|
| P30AI073961 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Other | Participation in 4 time matched sessions on health education topics |
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| PartnerPlus intervention | Experimental | Four group counseling sessions focused on prevention of mother to child transmission (PMTCT) sexual risk reduction & adherence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PartnerPlus Intervention | Behavioral | 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. |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl Peltzer, PhD | Human Sciences Research Council | Study Director |
| Deborah Jones, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Sciences Research Council | Pretoria | Gauteng | South Africa |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Usual Care | Other | 4 time matched sessions focused on health education |
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| 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 |