N/A
N=1,967
Implementing a Comprehensive Prevention of Mother-to-Child Transmission of HIV Program for South African Couples
HIV · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02085356 ↗Enrolled (actual)
1,967
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Dried Blood Spot Analysis of Medication Adherence- Mother and Infant — 56; 157; 35; 183 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Protect your family (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dried Blood Spot Analysis of Medication Adherence- Mother and Infant |
56; 157; 35; 183 | — |
| PRIMARY Infant HIV Seroconversions |
0; 4; 0; 4 | — |
| SECONDARY Mother Reported Rates of Infant Exclusive Breastfeeding |
102; 71; 169; 132 | 0.605 |
| SECONDARY Attendance at Scheduled Ante and Postnatal Clinic Appointments |
99; 0; 187 | 0.902 |
Summary
This study will test the effectiveness of a behavioral intervention to increase Prevention of Mother-to-Child Transmission of HIV (PMTCT) protocol uptake among South African HIV positive pregnant women. This study will also determine whether the participation of male partners will have additional positive impact on PMTCT uptake. The intervention will utilize a combination of both gender-concordant groups and individual or couples counseling strategies, before and after birth. During antenatal care, the intervention will use a gender-concordant group format to address PMTCT information, HIV disclosure, coping with stigma, intimate partner violence, and adherence to the overall PMTCT protocol. Just prior to birth and following birth, the intervention will shift to individual or couples-based counseling, targeting medication adherence, safer infant feeding, and family planning. It is hypothesized that women attending the intervention will be more likely to properly take HIV medication before birth and provide it to their infants. Additionally, it is hypothesized that male partner involvement will further increase the likelihood that mothers will take their HIV medication as prescribed and provide it to their infants.
Eligibility Criteria
Inclusion Criteria
- HIV seropositive pregnant women with partners, 20-24 weeks pregnant (typical time of entry into antenatal clinic care), aged >18.
- In Phase 2 (couples phase), both women and their partners will be enrolled. For the purposes of this study, primary male partners are defined as 1) husband, 2) current baby's father, or 3) current sexual partner.
Exclusion Criteria
- Persons actively psychotic (auditory or visual hallucination) or intoxicated (e.g., under the influence of alcohol of illegal drugs) will not be eligible and will be referred for treatment. Following resolution of symptoms, these persons will be eligible for the study. N.B.: Any person presenting for sessions actively psychotic or intoxicated will be referred for treatment and will not be eligible to participate in sessions until symptoms are resolved due to reduced likelihood of benefit from sessions.
Data sourced from ClinicalTrials.gov (NCT02085356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.