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

Human Immunodeficiency Virus Clinical Trial

— Tatua  

Official title:

Piloting Risk Stratification and Tailored Interventions With Pregnant and Postpartum Women With HIV in Kenya to Prevent Disengagement From Care and Viral Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841797
• Other study ID #: 22-1946
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Lisa Abuogi, MD, MSc
• Phone: 303-724-9383
• Email: lisa.abuogi[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• In-Person Program Management Plus (PM+)
PM+ sessions conducted via home visits from community mentor mothers
• Mobile Program Management Plus (mHealth PM+)
PM+ sessions conducted via phone

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Nairobi

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Johns Hopkins University, Kenya Medical Research Institute, University of Alabama at Birmingham

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the combined retention and treatment failure outcome	The change in the combined outcome of a missed visit (>28 days) or treatment failure (elevated VL>= 200 copies/ml among PWLWH assessed through medical records between baseline, 3 months postpartum, and 6 months postpartum.	Baseline, 3 months postpartum, 6 months postpartum
Secondary	Depression	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.	Baseline, 3 months postpartum, 6 months postpartum
Secondary	Psychological Outcome Profiles	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.	Baseline, 3 months postpartum, 6 months postpartum
Secondary	Fidelity - Content	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.	6 months postpartum
Secondary	Fidelity - Coverage	Fidelity coverage will be reached if 80% or more of study participants will complete the expected number of sessions.	6 months postpartum
Secondary	Feasibility - Recruitment	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.	Enrollment
Secondary	Acceptibility	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.	6 months postpartum