Clinical trial NCT05841797: Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV Transmission
Prevention of Mother to Child Transmission
Linkage to care
Retention in care
Community Mentor Mothers
Mobile intervention
Antiretroviral therapy adherence
Infant Health
Maternal CD4/viral loads
Early infant diagnosis
Acceptability of interventions
Vertical transmission
Mental health
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Kenya Medical Research Institute
name: Johns Hopkins University
First posted: 2023-05-03
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct a pilot hybrid type 2 effectiveness-implementation trial in which pregnant women at higher risk for missed visits and treatment failure are randomized to one of three study arms 1:1:1 standard of care, mHealth PM+, or in-person PM+ and followed through 6 months postpartum. Feasibility, acceptability, intervention satisfaction, and preliminary efficacy on mental health and HIV outcomes (combined outcome of continuous viral suppression and engagement in care) will be assessed.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Combined retention and treatment failure outcome
timeFrame: Baseline, 3 months postpartum, 6 months postpartum
Secondary outcomes:
measure: Depression
timeFrame: Baseline, 3 months postpartum, 6 months postpartum
measure: Psychological Outcome Profiles
timeFrame: Baseline, 3 months postpartum, 6 months postpartum
measure: Fidelity - Content
timeFrame: 6 months postpartum
measure: Fidelity - Coverage
timeFrame: 6 months postpartum
measure: Feasibility - Recruitment
timeFrame: Enrollment
measure: Acceptibility
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: University of Colorado, Denver
name: Lisa Abuogi, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: