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Completed

NCT Number: NCT05841797

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

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Personal Satisfaction Psychological Well-Being RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute

Nairobi, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-Person Program Management Plus (PM+)

Behavioral

PM+ sessions conducted in-person by mentor mothers

Mobile Program Management Plus (mHealth PM+)

Behavioral

PM+ sessions conducted via phone

Primary outcomes

  1. Combined retention and treatment failure outcome

    Time frame: Baseline, 3 months postpartum, 6 months postpartum

    Failure will be outcome of a missed visit (>30 days) OR treatment failure (elevated VL>= 200 copies/ml among PWLWH assessed through medical records from baseline to 6 months postpartum.

Secondary outcomes

  1. Depression

    Time frame: 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.

  2. Psychological Outcome Profiles

    Time frame: 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.

  3. Fidelity - Content

    Time frame: 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.

  4. Fidelity - Coverage

    Time frame: 6 months postpartum

    Fidelity coverage will be reached if 80% or more of study participants will complete the expected number of sessions.

  5. Feasibility - Recruitment

    Time frame: 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.

  6. Acceptibility

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Johns Hopkins University
  • Kenya Medical Research Institute
  • University of Alabama at Birmingham

Registry information

Official study title

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

Acronym: Tatua

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 3, 2023
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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