NCT05841797Completed
Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya
Piloting Risk Stratification and Tailored Interventions With Pregnant and Postpartum Women With HIV in Kenya to Prevent Disengagement From Care and Viral Failure
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 4 Apr 2023
- Start date
- 5 Jun 2023
- Primary completion date
- 12 Aug 2025
- Lead sponsor
- University of Colorado, Denver
- Diseases
- HIV
- NCT number
- NCT05841797
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 5 Jun 2023 to the primary completion date, 12 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Imminent plans of suicide and severe impairment due to severe mental, neurological or substance use disorders
Lab values
- Not HIV-infected at time of first ANC visit
Age
- Less than 15 years of age
- Less than 20 weeks estimated gestational age or not currently pregnant
Who the study is looking for
- 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.
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kenya Medical Research Institute Coordinator of this site? Confirm its status | Nairobi | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.