Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Behavioral: Home visits
* Behavioral: HIV Self-testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 15 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home visits<br>Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker. | Behavioral: Home visits<br>* If a couple has been randomized to the home visit intervention arm, a lay health worker will obtain detailed locator information (including cell phone contacts) and consult with the couple about optimal times for a home visit. As described above, the intervention arm will consist of five home visits conducted by one female and one male lay health worker, including two home visits during pregnancy, one at six weeks after the birth, and two booster sessions, one at six months after the birth and one at 12 months after the birth. Home visits are designed for all pregnant couples (regardless of woman's initial HIV test result at the antenatal clinic) and include topics important for maternal, paternal, and child health during pregnancy and postpartum.<br>|
| Active Comparator: HIV Self-testing<br>Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points. | Behavioral: HIV Self-testing<br>* Women in this study group will receive oral-fluid-based rapid HIV test kits for themselves and their male partner at up to 4 time points (twice during pregnancy and twice postpartum). Each test will be accompanied with a self-testing instruction sheet describing step-by-step procedures in multiple languages. Study staff will also conduct a brief demonstration on how to use the tests. Participants will be encouraged to offer a test kit to their male partner or to undertake couples testing. They will also be counseled on how to talk to their partners and the possibility of adverse partner reactions. Participants will be instructed to seek clinic-based confirmatory testing if a reactive self-test result is obtained.<br>|
| No Intervention: Standard Care<br>Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in couple HIV testing uptake from baseline to 12 months postpartum (all couples) | 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. | Baseline, 3 months postpartum, 12 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV re-testing | 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. | Baseline, 3 months postpartum, 12 months postpartum | 
| Number of new male HIV-positive diagnoses | 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. | Baseline, 3 months postpartum, 12 months postpartum | 
| Number of new discordant couples | 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. | Baseline, 3 months postpartum, 12 months postpartum | 
| Use of PMTCT interventions (for HIV-positive women only) | 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. | 3 months postpartum, 12 months postpartum, 18 months postpartum | 
| Utilization of maternal and child health (MCH) services (all couples in the study) | 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. | 3 months postpartum, 12 months postpartum, 18 months postpartum | 
| Pre-Exposure Prophylaxis (PrEP) uptake (discordant partners at follow-ups) | 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. | 3 months postpartum, 12 months postpartum, 18 months postpartum | 
| Woman's linkage to HIV care (HIV-positive women) | 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. | Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum | 
| Woman's enrollment in HIV care (HIV-positive women) | 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. | Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum | 
| Woman's adherence to HIV care (HIV-positive women) | 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. | Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum | 
| Number of HIV care visits (HIV-positive women) | 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. | Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum | 
| Man's linkage to HIV care (HIV-positive men) | 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. | Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth | 
| Man's enrollment in HIV care (HIV-positive men) | 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. | Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth | 
| Man's adherence to HIV care (HIV-positive men) | 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. | Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth | 
| Number of HIV care visits (HIV-positive men) | 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. | Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth | 
| Maternal HIV viral suppression (HIV-positive women) | Viral Load < 200 copies (undetectable) for all HIV-positive women at baseline and 18 months postpartum through medical records. | Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum | 
| HIV-free child survival | Child alive and HIV-free at 18 months after the birth. This is assessed in a brief interview and confirmed through medical records. | 18 months after the birth | 
| Result of infant HIV test | Result of infant HIV test based on medical records. | 3 months after birth, 12 months after birth, 18 months after birth | 
| Date of infant HIV test | Date of infant HIV test based on medical records. | 3 months after birth, 12 months after birth, 18 months after birth |