Trial reportThe lancet. HIV2026
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.
Trial report in The lancet. HIV, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03547739 (Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya), which is not on this map. Not yet cited in PubMed.
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Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
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Authors and funding
12 authors.
Funding
Abstract
backgroundEngaging 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.
methodsIn 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.
findingsBetween 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).
interpretationBoth 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.
fundingNational Institute of Mental Health. TRANSLATION: For the Kiswahili translation of the abstract see Supplementary Materials section.
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