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Peer-reviewedCC BY-NC-NDThe Lancet HIV

Effectiveness of interventions to promote couples-based HIV testing and family health during pregnancy and postpartum in Kenya: a multicentre, couples-based, randomised controlled trial

8 affiliations
  1. 1Department of Health Policy and Organization, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: [email protected]
  2. 2Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya
  3. 3Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA
  4. 4Department of Health Policy and Organization, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA
  5. 5Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
  6. 6Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA
  7. 7Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
  8. 8Department of Health Behavior and Clinical Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, USA

Abstract

BACKGROUND: Engaging couples during pregnancy can improve HIV prevention and family health. We examined the effectiveness of two couples-focused interventions on uptake of couples HIV testing and counselling (CHTC) and maternal and child health outcomes. METHODS: In this multicentre, couples-based, randomised controlled trial, HIV status-concordant and HIV status-discordant pregnant couples (aged ≥15 years) from 24 antenatal clinics across Migori and Kisumu counties in Kenya were randomly assigned (1:1:1) to one of three study groups: lay counsellors delivered five couple home visits on health and relationship skills and offered CHTC at home (home visit group); HIV self-test kits were given to women to use with their partners (HIV self-test group); standard care access with routine perinatal health services offered at their health facility, including offers of individual and couples HIV testing (standard care group). Couples were followed up to 18 months postpartum. The primary outcome was both couple members reporting CHTC uptake by 12 months postpartum. For analyses, we used generalised linear and generalised estimating equation models. This trial is registered at ClinicalTrials.gov, NCT03547739, and is complete. FINDINGS: Between March 20, 2019, and July 26, 2022, we recruited and randomly assigned 800 couples to the home visit group (n=267), HIV self-test group (n=266), or standard care group (n=267). Two-thirds (n=533 [66·7%]) of couples included a woman living with HIV. CHTC uptake was higher in the home visit group and HIV self-test group, with 114 (56·2%; adjusted risk ratio 4·22 [95% CI 2·88-6·18]) and 106 (50·0%; 3·69 [2·50-5·45]) couples reporting CHTC by 12 months, compared with 26 (13·6%) in the standard care group. We reported 54 severe adverse events (adverse pregnancy outcomes, none related to study procedures) and 37 adverse events (two possibly related to study procedures). INTERPRETATION: Both home visits and HIV self-test kits offer a gateway for positive health outcomes for perinatal women and families. Home visits, which directly engage both members of the couple, can provide additional advantages for HIV-related health. FUNDING: National Institute of Mental Health. TRANSLATION: For the Kiswahili translation of the abstract see Supplementary Materials section.

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BibTeX
@article{turan2026effectiveness,
  title = {{Effectiveness of interventions to promote couples-based HIV testing and family health during pregnancy and postpartum in Kenya: a multicentre, couples-based, randomised controlled trial}},
  author = {Janet M. Turan and Zachary Kwena and Kevin Owuor and Anna Helová and Abigail M. Hatcher and Thomas Braun and Evelyne Owengah and Moses Okombo and Van Thi Ha Nghiem and Harsha Thirumurthy and Elizabeth Anne Bukusi and Lynae A. Darbes},
  journal = {The Lancet HIV},
  year = {2026},
  month = jun,
  doi = {10.1016/s2352-3018(26)00104-9},
  url = {https://doi.org/10.1016/s2352-3018(26)00104-9},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Effectiveness of interventions to promote couples-based HIV testing and family health during pregnancy and postpartum in Kenya: a multicentre, couples-based, randomised controlled trial
AU  - Janet M. Turan
AU  - Zachary Kwena
AU  - Kevin Owuor
AU  - Anna Helová
AU  - Abigail M. Hatcher
AU  - Thomas Braun
AU  - Evelyne Owengah
AU  - Moses Okombo
AU  - Van Thi Ha Nghiem
AU  - Harsha Thirumurthy
AU  - Elizabeth Anne Bukusi
AU  - Lynae A. Darbes
PY  - 2026
DA  - 2026/06/29
JO  - The Lancet HIV
DO  - 10.1016/s2352-3018(26)00104-9
UR  - https://doi.org/10.1016/s2352-3018(26)00104-9
AB  - BACKGROUND: Engaging couples during pregnancy can improve HIV prevention and family health. We examined the effectiveness of two couples-focused interventions on uptake of couples HIV testing and counselling (CHTC) and maternal and child health outcomes. METHODS: In this multicentre, couples-based, randomised controlled trial, HIV status-concordant and HIV status-discordant pregnant couples (aged ≥15 years) from 24 antenatal clinics across Migori and Kisumu counties in Kenya were randomly assigned (1:1:1) to one of three study groups: lay counsellors delivered five couple home visits on health and relationship skills and offered CHTC at home (home visit group); HIV self-test kits were given to women to use with their partners (HIV self-test group); standard care access with routine perinatal health services offered at their health facility, including offers of individual and couples HIV testing (standard care group). Couples were followed up to 18 months postpartum. The primary outcome was both couple members reporting CHTC uptake by 12 months postpartum. For analyses, we used generalised linear and generalised estimating equation models. This trial is registered at ClinicalTrials.gov, NCT03547739, and is complete. FINDINGS: Between March 20, 2019, and July 26, 2022, we recruited and randomly assigned 800 couples to the home visit group (n=267), HIV self-test group (n=266), or standard care group (n=267). Two-thirds (n=533 [66·7%]) of couples included a woman living with HIV. CHTC uptake was higher in the home visit group and HIV self-test group, with 114 (56·2%; adjusted risk ratio 4·22 [95% CI 2·88-6·18]) and 106 (50·0%; 3·69 [2·50-5·45]) couples reporting CHTC by 12 months, compared with 26 (13·6%) in the standard care group. We reported 54 severe adverse events (adverse pregnancy outcomes, none related to study procedures) and 37 adverse events (two possibly related to study procedures). INTERPRETATION: Both home visits and HIV self-test kits offer a gateway for positive health outcomes for perinatal women and families. Home visits, which directly engage both members of the couple, can provide additional advantages for HIV-related health. FUNDING: National Institute of Mental Health. TRANSLATION: For the Kiswahili translation of the abstract see Supplementary Materials section.
SN  - 2352-3018
SN  - 2405-4704
ER  -