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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    1600
  • sponsor
    University of Alabama at Birmingham
Updated on 14 June 2021
hiv test
PMTCT
HIV Vaccine

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.

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.

Details
Condition HIV, HIV infection, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease
Treatment Home visits, Home visits, HIV Self-testing
Clinical Study IdentifierNCT03547739
SponsorUniversity of Alabama at Birmingham
Last Modified on14 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Women at 36 weeks of pregnancy or less
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
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