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

Sponsor
University of Alabama at Birmingham
Study ID
NCT03547739
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Home visits — BEHAVIORAL
    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.
  • HIV Self-testing — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 20, 2019
Status verified
Jul 2025
Primary completion
Jun 27, 2024
Completion
Oct 23, 2024

Study Design

Enrollment
1,600 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Home visits
    Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.
  • Active Comparator: 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.
  • No Intervention: Standard Care
    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).

Primary Outcome Measure

Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum [ Time Frame: up to 12 months postpartum ]

Related Studies