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

NCT03547739 | Completed Results DMC

• 3 other identifiers: IRB-300001427000518108R01MH116736
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum

  Number of couples with couple HIV testing uptake during observation period (from baseline to 12 months postpartum), coded as Y=if the couple tested together for HIV up to 12 months postpartum and N=if the couple has not tested together for HIV up to 12 months postpartum. At 3 and 12 months postpartum, each couple member was asked to report whether they had tested together for HIV as a couple at home with HIV self-test kits or at the clinic.

  up to 12 months postpartum

Secondary Outcomes (18)

• HIV Re-testing

  Up to 12 months postpartum

• Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (Intervention Arms Only)

  Up to 12 months postpartum

• Number of New Discordant Couples (Intervention Arms Only)

  Up to 12 months postpartum

• HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum

  Up to 18 months postpartum

• Women Who Utilized All 4 MCH Services up to 3 Months Postpartum

  Up to 3 months postpartum

Study Arms (3)

Home visits

ACTIVE COMPARATOR

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

Behavioral: Home visits

HIV Self-testing

ACTIVE COMPARATOR

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

Standard Care

NO INTERVENTION

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).

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.

Home visits

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.

HIV Self-testing

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Kenya Medical Research Institute: collaborator
• University of Michigan: collaborator
• University of Witwatersrand, South Africa: collaborator
• University of Pennsylvania: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Kenya Medical Research Institute

Nairobi, Kenya

Location

Related Publications (2)

• Kwena Z, Kimbo L, Darbes LA, Hatcher AM, Helova A, Owino G, Thirumurthy H, Bukusi EA, Braun T, Kilgore M, Pisu M, Tamhane A, Nghiem VT, Agot K, Neilands TB, Turan JM. Testing strategies for couple engagement in prevention of mother-to-child transmission of HIV and family health in Kenya: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):19. doi: 10.1186/s13063-020-04956-1.

  PMID: 33407784 RESULT

• Borgstede SJ, Elly A, Helova A, Kwena Z, Darbes LA, Hatcher A, Thirumurthy H, Owino G, Pisu M, Owuor K, Braun T, Turan JM, Bukusi EA, Nghiem VT. Cost of Home-Based Couples Human Immunodeficiency Virus Counseling and Testing and Human Immunodeficiency Virus Self-Testing During Pregnancy and Postpartum in Southwestern Kenya. Value Health Reg Issues. 2023 Mar;34:125-132. doi: 10.1016/j.vhri.2022.11.003. Epub 2023 Jan 27.

  PMID: 36709657 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

House Calls

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Limitations and Caveats

Investigators enrolled a selected sample of couples who were living together in stable relationships with both partners of the couple willing to participate in the research. The study used self-report measures for the primary outcome of CHTC for the comparison groups and several of the intermediate variables, which may be subject to recall and other reporting biases. Another limitation was introduced by the occurrence of the COVID-19 pandemic in the middle of the study period.

Results Point of Contact

• Title: Janet M. Turan, PhD, MPH
• Organization: University of Alabama at Birmingham

jmturan@uab.edu

2059757770

Study Officials

• Janet M Turan, PhD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Lynae Darbes, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 6, 2018
• Study Start: March 20, 2019
• Primary Completion: June 27, 2024
• Study Completion: October 23, 2024
• Last Updated: September 26, 2025
• Results First Posted: September 26, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)