Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya (Jamii Bora)

The University of Alabama at Birmingham

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Behavioral: Home visits; Behavioral: HIV Self-testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03547739

000518108 (Other Identifier)

IRB-300001427

R01MH116736 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,600 participants in 3 patient groups

Home visits

Active Comparator group

Description:

Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.

Treatment:

Behavioral: Home visits

HIV Self-testing

Active Comparator group

Description:

Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.

Treatment:

Behavioral: HIV Self-testing

Standard Care

No Intervention group

Description:

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).