Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Behavioral: HIV Self-testingBehavioral: Home visits
- Registration Number
- NCT03547739
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
This study will test the efficacy and cost-effectiveness of an interdependence theory-based couples intervention in Kenya that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services.
- Detailed Description
Despite the potential for antiretroviral therapy to improve maternal health and reduce mother-to-child transmission of HIV to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. This is particularly true in Kenya, where crucial drop-offs occur in the cascade of prevention of mother-to-child transmission (PMTCT) services. Weak health systems contribute to insufficient service coverage, but many barriers lie beyond the clinic-in the partner, family, and community factors that shape women's health decisions. The investigators' research in a high HIV prevalence area of southwestern Kenya has shown that many women avoid couples HIV testing and do not adhere to PMTCT regimens because they fear negative consequences from a male partner. Men can play a crucial supportive role for family health, but male partners in Kenya are poorly engaged in antenatal care and uptake of couples HIV testing during pregnancy is low. Pregnant women desire to be tested for HIV together with their partner and need the support for mutual disclosure involved in couples HIV testing and counseling (CHTC), regardless of whether they know their own HIV status. In this context, the investigators will test the efficacy of an interdependence theory-based couples intervention that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services. The randomized pilot study of this intervention with 96 pregnant couples (R34MH102103) demonstrated significant increases in uptake of couples testing (64% in intervention vs. 23% in control, p\<0.001) and significant improvements in health behaviors such as exclusive breastfeeding and postpartum care. The investigators will now conduct a more robust investigation to determine whether this intervention improves uptake of couples HIV testing and health outcomes over and above less intensive male engagement strategies being used in the region. This theory-based couples intervention has strong potential to increase couple HIV testing and collaboration for family health. The study will inform decision-makers about cost-effective strategies to engage pregnant couples in PMTCT and family health, with important downstream benefits for maternal, paternal, and infant health.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1600
- Women at 36 weeks of pregnancy or less
- 15 years of age or older
- Has been offered HIV testing at ANC
- Is currently in a stable relationship with a male partner and living with that male partner - Has not yet participated in couple HIV testing during this pregnancy.
- Male partner is the person identified by the pregnant woman as her primary male partner and should also be 15 years of age or older.
- Not in an HIV-positive concordant relationship.
- Greater than 36 weeks of pregnancy
- Less than 15 years of age
- Not currently in a stable relationship with a male partner
- Does not currently live with male partner
- Has not been offered HIV testing at ANC
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HIV Self-testing HIV Self-testing Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points. Home visits Home visits Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.
- Primary Outcome Measures
Name Time Method Change in couple HIV testing uptake from baseline to 12 months postpartum (all couples) Baseline, 3 months postpartum, 12 months postpartum Change in couples HIV testing uptake during observation period (from baseline to 12 months postpartum), coded as Y/N. This is assessed in the questionnaires for all couples regardless of HIV status at baseline and each follow-up until 12 months postpartum and confirmed through medical records.
- Secondary Outcome Measures
Name Time Method Number of new discordant couples Baseline, 3 months postpartum, 12 months postpartum Number of new HIV serodiscordant couples identified during observation period. This is assessed for all couples at baseline and each follow-up until 12 months postpartum in the questionnaires and confirmed through medical records.
Woman's linkage to HIV care (HIV-positive women) Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum Time to linkage to HIV care assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.
Woman's enrollment in HIV care (HIV-positive women) Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum Enrollment of HIV-positive women in HIV care (Y/N) assessed at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.
Man's linkage to HIV care (HIV-positive men) Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth Time to linkage to HIV care assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.
HIV re-testing Baseline, 3 months postpartum, 12 months postpartum Re-testing for HIV during pregnancy and postpartum during observation period assessed in the questionnaire and confirmed through medical records, completed by all participants at baseline and each follow-up until 12 months postpartum.
Woman's adherence to HIV care (HIV-positive women) Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum Self-reported adherence to HIV care assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.
Number of new male HIV-positive diagnoses Baseline, 3 months postpartum, 12 months postpartum Number of new HIV-positive test results of male partners during observation period, coded as Y/N. This is assessed for all male participants at baseline and each follow-up until 12 months postpartum in the questionnaires and confirmed through medical records.
Utilization of maternal and child health (MCH) services (all couples in the study) 3 months postpartum, 12 months postpartum, 18 months postpartum Composite variable including at having completed least four antenatal care (ANC) visits during pregnancy (Y/N), childbirth with a skilled attendant (Y/N), and postnatal check-ups for woman (Y/N) and infant (Y/N). These are assessed in the follow-up questionnaires completed up to 18 months postpartum.
Number of HIV care visits (HIV-positive men) Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth Number of HIV care visits assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.
Result of infant HIV test 3 months after birth, 12 months after birth, 18 months after birth Result of infant HIV test based on medical records.
Man's adherence to HIV care (HIV-positive men) Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth Self-reported adherence to HIV care assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.
Maternal HIV viral suppression (HIV-positive women) Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum Viral Load \< 200 copies (undetectable) for all HIV-positive women at baseline and 18 months postpartum through medical records.
Use of PMTCT interventions (for HIV-positive women only) 3 months postpartum, 12 months postpartum, 18 months postpartum Composite variable including mothers use of antiretrovirals (ARVs) (Y/N), prophylactic ARVs given to the infant (Y/N), and appropriate infant feeding practices. These are assessed in the questionnaires completed at each follow-up up to 18 month postpartum.
Pre-Exposure Prophylaxis (PrEP) uptake (discordant partners at follow-ups) 3 months postpartum, 12 months postpartum, 18 months postpartum Initiation of PrEP by discordant partners assessed at each follow-up in the questionnaires and confirmed through through medical records up to 18 months after the baby's birth.
Number of HIV care visits (HIV-positive women) Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum Number of HIV care visits assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.
Man's enrollment in HIV care (HIV-positive men) Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth Enrollment of HIV-positive men in HIV care (Y/N) assessed at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.
Date of infant HIV test 3 months after birth, 12 months after birth, 18 months after birth Date of infant HIV test based on medical records.
HIV-free child survival 18 months after the birth Child alive and HIV-free at 18 months after the birth. This is assessed in a brief interview and confirmed through medical records.
Trial Locations
- Locations (1)
Kenya Medical Research Institute
🇰🇪Nairobi, Kenya