NCT03547739: Jamii Bora

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

Completed NA Results posted Last updated 26 September 2025

What this trial tests

NA trial testing Home visits in Human Immunodeficiency Virus in 1,600 participants. Completed in 23 October 2024.

Timeline

20 March 2019

Primary endpoint
27 June 2024

23 October 2024

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,600
Start date	20 March 2019
Primary completion	27 June 2024
Estimated completion	23 October 2024
Sites	1 location across Kenya

Drugs / interventions tested

• Home visits
• HIV Self-testing

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →

Sponsor

University of Alabama at Birmingham

Who can join

15 and older, any sex, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Home Visits	114
HIV Self-testing	106
Standard Care	26

HIV Re-testing Secondary · Up to 12 months postpartum

Re-testing for HIV during pregnancy and postpartum during observation period assessed in the questionnaire.

Group	Value	95% CI
Home Visits	338
HIV Self-testing	367
Standard Care	258

Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (Intervention Arms Only) Secondary · Up to 12 months postpartum

Number of new HIV-positive test results of male partners from baseline to 12 months postpartum and coded as Y=those who had tested for HIV individually up to 12 months postpartum and N=those who had not tested for HIV individually up to 12 months postpartum.

Group	Value	95% CI
Home Visits	9
HIV Self-testing	2

Number of New Discordant Couples (Intervention Arms Only) Secondary · Up to 12 months postpartum

Number of new HIV serodiscordant couples identified during observation period.

Group	Value	95% CI
Home Visits	93
HIV Self-testing	35
Standard Care	0

HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum Secondary · Up to 18 months postpartum

Composite variable based on self-report data from women's questionnaires, coded as Y=those who were coded as Y on the three variables described below and N= those who were coded as N on one, two, or three variables described below: (1) mothers use of antiretrovirals (ARVs) (Y=those mothers who have used ARVs from baseline up to 18 months postpartum/N=those mothers who have not used ARVs at any time point between baseline up to 18 months postpartum), (2) prophylactic ARVs given to the infant (Y=those infants who were given prophylactic ARVs up to 18 months after the birth/N=those infants who we

Group	Value	95% CI
Home Visits	31
HIV Self-testing	28
Standard Care	28

Women Who Utilized All 4 MCH Services up to 3 Months Postpartum Secondary · Up to 3 months postpartum

Composite variable based on self-report data from women's questionnaires: Y=if all described variables coded as Y, N=if at least one of the following variables coded as N: (1) Y=if a woman completed at least four antenatal care (ANC) visits during this pregnancy, N=if a woman completed less than four ANC visits during this pregnancy; (2) Y=if a childbirth was with a skilled attendant, N=if a childbirth was not with a skilled attendant; (3) Y=if a postpartum check-up was completed for a woman and N=if the women did not have a postpartum check-up, and (4) Y=if the infant had a postnatal check-up

Group	Value	95% CI
Home Visits	116
HIV Self-testing	103
Standard Care	91

Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative at Baseline) Secondary · Up to 18 months postpartum

Initiation of PrEP by participants with HIV-negative status at baseline, assessed at each follow-up in the questionnaires up to 18 months after the baby's birth.

Group	Value	95% CI
Home Visits	47
HIV Self-testing	49
Standard Care	46

Number of HIV-positive Women Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum Secondary · Up to 12 months postpartum

Number of HIV-positive women not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum assessed at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive woman at baseline and not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum. Coded as N=if HIV-positive woman at baseline and not linked to HIV care at baseline reported not being linked to HIV care at 12 months postpartum.

Group	Value	95% CI
Home Visits	4	0 – 0
HIV Self-testing	1	0 – 22.9
Standard Care	1	0 – 3.3

Number of HIV-positive Women at Baseline Retained in HIV Care up to 12 Months Follow-up Secondary · Up to 12 months postpartum

Woman's retention in HIV care assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive woman at baseline was retained in HIV care up to 12 months postpartum and N=if HIV-positive woman at baseline has not been retained in HIV up to 12 months postpartum.

Group	Value	95% CI
Home Visits	151
HIV Self-testing	165
Standard Care	159

Mean Woman's Adherence to HIV Treatment (ART) (HIV-positive Women Retained up to 12-months Follow-up) Secondary · Up to 12 months postpartum

Mean self-reported adherence to ART was assessed using self-report questionnaire data for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum. Adherence was measured using a 3-item adherence scale (Wilson et al., 2014) with items on number of missed doses, self-evaluation of how good a job she was doing with adherence, and how often taken as recommended; all for the last 30 days. An adherence score (possible range 0-100%) was calculated for each woman at each time point.

Group	Value	95% CI
Home Visits	73.9	± 7.5
HIV Self-testing	71.8	± 7.4
Standard Care	71.3	± 8.8

Mean Number of HIV Care Visits (HIV-positive Women Retained up to 12-months Follow-up) Secondary · Up to 12 months postpartum

Mean number of HIV care visits assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records.

Group	Value	95% CI
Home Visits	4.7	± 1.3
HIV Self-testing	4.7	± 1.4
Standard Care	4.7	± 1.3

Number of HIV-positive Men Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum Secondary · Up to 12 months postpartum

Number of HIV-positive men not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum assessed at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive man at baseline and not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum. Coded as N=if HIV-positive man at baseline and not linked to HIV care at baseline reported not being linked to HIV care at 12 months postpartum.

Group	Value	95% CI
Home Visits	2
HIV Self-testing	1

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment until end of follow-up: up to 18 months postpartum. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Home Visits

Serious: 24/534 (4%)

Deaths: 0/534

HIV Self-testing

Serious: 11/532 (2%)

Deaths: 1/532

Standard Care

Serious: 13/534 (2%)

Deaths: 5/534

Serious adverse events (6 terms)

Reaction	System	Home Visits	HIV Self-testing	Standard Care
Neonatal Deaths	Pregnancy, puerperium and perinatal conditions	—	—	—
Stillbirth	Pregnancy, puerperium and perinatal conditions	—	—	—
Infant Deaths	Pregnancy, puerperium and perinatal conditions	—	—	—
Miscarriage	Pregnancy, puerperium and perinatal conditions	—	—	—
Child death	Pregnancy, puerperium and perinatal conditions	—	—	—
Hospitalization	Pregnancy, puerperium and perinatal conditions	—	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Home Visits	HIV Self-testing	Standard Care
Separation/relationship dissolution	Social circumstances	—	—	—
New intimate partner violence	Social circumstances	—	—	—
Depression	Psychiatric disorders	—	—	—

Most-reported serious reactions: Neonatal Deaths, Stillbirth, Infant Deaths, Miscarriage, Child death, Hospitalization.

Data from ClinicalTrials.gov NCT03547739 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Kwena Z, Kimbo L, Darbes LA, Hatcher AM, et al · · 2021 · cited 12× · PMID 33407784 · DOI 10.1186/s13063-020-04956-1
2. HIV-related stigma, couple relationship quality, and mental health in sero-discordant pregnant couples in Kenya.
   Buyukcan-Tetik A, Ergun TD, Turan B, Mukerji R, et al · · 2026 · cited 1× · PMID 41607089 · DOI 10.1111/aphw.70120
3. Cost of Home-Based Couples Human Immunodeficiency Virus Counseling and Testing and Human Immunodeficiency Virus Self-Testing During Pregnancy and Postpartum in Southwestern Kenya.
   Borgstede SJ, Elly A, Helova A, Kwena Z, et al · · 2023 · cited 1× · PMID 36709657 · DOI 10.1016/j.vhri.2022.11.003
4. Pathways between intimate partner violence and HIV care and treatment during pregnancy and postpartum: A qualitative study in southwestern Kenya.
   Schrubbe L, Makokha C, Kimbo L, Helova A, et al · · 2025 · PMID 40901769 · DOI 10.1371/journal.pgph.0004163