Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Behavioral: In-Person Program Management Plus (PM+)Behavioral: Mobile Program Management Plus (mHealth PM+)
- Registration Number
- NCT05841797
- Lead Sponsor
- University of Colorado, Denver
- Brief 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.
- Detailed Description
Among pregnant/postpartum women living with HIV (PWLWH) in low resource, high HIV prevalence settings, access to antiretroviral treatment (ART) has increased dramatically and mother-to-child transmission (MTCT) of HIV has decreased substantially, yet successful outcomes are not universal. Despite a 52% decline in new HIV infections among children under five from 2010-2019, recent UNAIDS data indicate global targets were missed by wide margins, with an estimated 160,000 new pediatric HIV infections annually. Sub-optimal retention of PWLWH is a major contributor to new pediatric infections. 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. As PMTCT programs in sub-Saharan Africa (SSA) aim for the elimination of MTCT in the context of decreased funding, there is need for research geared towards identifying and supporting the most vulnerable PWLWH with tailored interventions that can be implemented using available resources. This study aims to build on a previous study, Mother and Infant Visit Adherence and Treatment Engagement Study (MOTIVATE, R01HD080477), to develop and implement interventions that can promote proper taking of HIV drugs among PWLWH, namely a risk calculator to identify women at high risk for treatment failure and an adapted Problem Management Plus (PM+) intervention specifically geared towards women identified as high risk. Such interventions are critical in order to identify the most vulnerable PWLWH as early as possible to intervene with effective targeted interventions that will help improve maternal and child health outcomes.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description In-Person Program Management Plus (PM+) In-Person Program Management Plus (PM+) For Arm 2, the investigators will implement the adapted PM+ utilizing the complete manual of operations and adaptation lessons learned in the non-clinical trial portion of the study. The investigators will train mentor mothers to serve as PM+ Helpers. In-person sessions will likely be delivered at home. Sessions will continue after the birth if not completed during pregnancy. PM+ Helpers will debrief regularly on the progress of participants with clinically trained supervisors - both for their own psychological well-being and to ensure that participants receive adequate care. Mobile Program Management Plus (mHealth PM+) Mobile Program Management Plus (mHealth PM+) For Arm 3, the investigators will implement the adapted PM+ utilizing the complete manual of operations and adaptation lessons learned in the non-clinical trial portion of the study. The investigators will train mentor mothers to serve as PM+ Helpers. In the mHealth delivered version of PM+, PM+ Helpers will conduct PM+ virtually after an initial meeting to create rapport. Sessions will be delivered by either 1) a PM+ Helper- initiated phone call or 2) a participant-initiated call via a call-in help line. Airtime will be provided so that participation will be free of charge. Sessions will continue after the birth if not completed during pregnancy. PM+ Helpers will debrief regularly on the progress of participants with clinically trained supervisors - both for their own psychological well-being and to ensure that participants receive adequate care.
- Primary Outcome Measures
Name Time Method Change in the combined retention and treatment failure outcome Baseline, 3 months postpartum, 6 months postpartum The change in the combined outcome of a missed visit (\>30 days) or treatment failure (elevated VL\>= 200 copies/ml among PWLWH assessed through medical records between baseline, 3 months postpartum, and 6 months postpartum.
- Secondary Outcome Measures
Name Time Method Fidelity - Content 6 months postpartum The fidelity content measure will be considered reached if 75% or more of observed intervention sessions have all the recommended intervention content fully covered as per the manual Key Points checklist.
Feasibility - Recruitment Enrollment The intervention will be considered feasible if the proportion of eligible women able to be recruited into the study per clinic per month equals or exceeds 80% of those eligible for recruitment.
Fidelity - Coverage 6 months postpartum Fidelity coverage will be reached if 80% or more of study participants will complete the expected number of sessions.
Acceptibility 6 months postpartum The intervention will be considered acceptable if 90% percent or more of intervention participants will rate the intervention completely acceptable. Acceptability will be assessed using items from the Theory-informed questionnaire to assess the acceptability of healthcare interventions. The acceptability outcome indicator will be based on one question from the questionnaire: "How acceptable was the intervention to you? Response options range from completely unacceptable (1) to completely acceptable(5). A higher score means higher acceptability. The intervention will be considered acceptable if 90% or more of intervention participants rate the intervention as completely acceptable.
Depression Baseline, 3 months postpartum, 6 months postpartum Depression score is calculated and severity assessed through a survey utilizing Patient Health Questionnaire Depression Scale (PHQ-9). PHQ-9 score is obtained by adding score for each question (total points). Total score of 0-4 suggests none to minimal depression severity, score of 5-9 mild depression severity, score of 10-14 moderate depression severity, a score of 15-19 moderately severe depression, and a score of 20-27 severe depression.
Psychological Outcome Profiles Baseline, 3 months postpartum, 6 months postpartum Psychological Profile of the study participant is assessed through a survey utilizing Psychological Outcomes Profile scale (PSYCHLOPS). The scale consists of four questions measuring three domains: Problems, Function and Wellbeing. The score is obtained by adding a score for each questions (total points). The maximum score for each question is 5. The maximum PSYCHLOPS score is 20. A higher score indicates a worse outcome.
Trial Locations
- Locations (1)
Kenya Medical Research Institute
🇰🇪Nairobi, Kenya