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N/A N=1,967 Randomized Prevention

Implementing a Comprehensive Prevention of Mother-to-Child Transmission of HIV Program for South African Couples

HIV · Pregnancy

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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