CompletedNot Applicable

Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya

Kenya120 participantsStarted 2023-06-05

Plain-language summary

This study includes secondary quantitative analysis, qualitative methods, and hybrid type 2 implementation-effectiveness pilot trial. The overall goal of this protocol is to determine whether risk stratification of PWLWH in conjunction with a tailored psychosocial support intervention can optimize health outcomes for the vulnerable women and infants. This study will be conducted in high-volume, low-resource health facilities in Kisumu County, Kenya, which is a priority area for research among WLWH and one of the highest HIV burden counties.

Who can participate

Age range15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Pregnant woman living with HIV attending an ANC clinic in Kisumu County, on/initiating ART * At least 15 years of age * At least 20 weeks estimated gestational age * At moderate or critical risk of the combined outcome of treatment disengagement or viral failure according to the risk calculator * Access to a cell phone (for those who share phones, have disclosed their HIV status to whomever individuals share the phone with. Exclusion Criteria: * Imminent plans of suicide and severe impairment due to severe mental, neurological or substance use disorders * Less than 15 years of age * Less than 20 weeks estimated gestational age or not currently pregnant * Not HIV-infected at time of first ANC visit

What they're measuring

Combined retention and treatment failure outcome

Timeframe: Baseline, 3 months postpartum, 6 months postpartum

Trial details

NCT IDNCT05841797

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-12

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