Trial results for strategies aimed at couple engagement in PMTCT and family health in Kenya were posted on ClinicalTrials.gov on 2025-09-26. The study found that both home visits and HIV self-testing significantly increased the number of couples who tested for HIV, with risk ratios of 4.22 and 3.69 respectively, compared to standard care.
Background
Human Immunodeficiency Virus (HIV) remains a significant global health challenge, particularly in regions like Kenya. Prevention of Mother-to-Child Transmission (PMTCT) programs are crucial for reducing new infections in infants. Engaging male partners in HIV testing and prevention efforts is vital for effective PMTCT and overall family health, as it can facilitate early diagnosis, treatment adherence, and reduce transmission risks within couples. This study investigated novel strategies to enhance couple engagement in these critical health services.
Trial design
This study, designated as 'NA' phase, enrolled 1600 participants. The trial focused on Human Immunodeficiency Virus. The study aimed to test the efficacy and cost-effectiveness of an interdependence theory-based couples intervention in Kenya. This intervention reached pregnant women and male partners through home visits by male-female pairs of lay health workers and included an offer of home-based Couple HIV Testing and Counseling (CHTC) services. The study compared two intervention arms: 'Home Visits' and 'HIV Self-testing', against a 'Standard Care' arm.
Key results
The study reported on several key measurements and analyses:
- Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum:
- In the Home Visits group, 114 couples tested for HIV as a couple.
- In the HIV Self-testing group, 106 couples tested for HIV as a couple.
- In the Standard Care group, 26 couples tested for HIV as a couple.
- HIV Re-testing:
- 338 participants in the Home Visits group re-tested for HIV.
- 367 participants in the HIV Self-testing group re-tested for HIV.
- 258 participants in the Standard Care group re-tested for HIV.
- Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (Intervention Arms Only):
- The Home Visits group reported 9 new male HIV-positive diagnoses.
- The HIV Self-testing group reported 2 new male HIV-positive diagnoses.
- Number of New Discordant Couples (Intervention Arms Only):
- There were 93 new discordant couples in the Home Visits group.
- There were 35 new discordant couples in the HIV Self-testing group.
- The Standard Care group reported 0 new discordant couples.
- HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum:
- In the Home Visits group, 31 HIV+ women utilized all three PMTCT interventions.
Key analyses using the Chi-squared method provided the following risk ratios:
- For the outcome of couples who tested for HIV as a couple, comparing Home Visits to Standard Care, the Risk Ratio (RR) was 4.22 (95.0% CI: 2.88, 6.18), with a p-value of 0.001.
- For the same outcome, comparing HIV Self-testing to Standard Care, the Risk Ratio (RR) was 3.69 (95.0% CI: 2.5, 5.45), with a p-value of 0.001.
- For HIV re-testing, comparing the Home Visit arm with Standard Care, the Risk Ratio (RR) was 1.21 (95.0% CI: 1.12, 1.31), with a p-value of 0.001.
- For HIV re-testing, comparing the HIV Self-testing arm with Standard Care, the Risk Ratio (RR) was 1.26 (95.0% CI: 1.17, 1.36), with a p-value of 0.001.
- Another comparison of the Home Visit arm with Standard Care yielded a Risk Ratio (RR) of 1.08 (95.0% CI: 1.03, 1.12), with a p-value of 0.011.
- A comparison of the HIV Self-testing arm with Standard Care yielded a Risk Ratio (RR) of 1.02 (95.0% CI: 0.97, 1.08), with a p-value of 0.011.
What this means
The results indicate that both home visit interventions and HIV self-testing strategies are effective in significantly increasing couple HIV testing and re-testing rates compared to standard care. The substantial risk ratios of 4.22 and 3.69 for couple HIV testing highlight the potential of these interventions to improve engagement in HIV prevention and care efforts. The increased identification of new discordant couples in the intervention arms suggests these approaches are successful in uncovering previously undiagnosed serodiscordant relationships, which is critical for targeted prevention strategies. These findings support the implementation of such community-based and self-testing interventions to enhance couple-based HIV services and contribute to PMTCT and family health initiatives in high-burden settings.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03547739, titled 'Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya', were posted on 2025-09-26 on clinicaltrials.gov.