Back to resultsEvaluation of Problem Management Plus in Pregnant Women With HIV in Kenya (Tatua)
Primary Purpose
Human Immunodeficiency Virus
Status
Not yet recruiting
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
In-Person Program Management Plus (PM+)
Mobile Program Management Plus (mHealth PM+)
Sponsored by
About this trial
This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring 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
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
Sites / Locations
- Kenya Medical Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Standard of Care (SOC)
In-Person Program Management Plus (PM+)
Mobile Program Management Plus (mHealth PM+)
Arm Description
Standard of Care (SOC): For Arm 1 of the pilot trial, SOC will be implemented. SOC for PWLWH in Kenya is carried out according Kenyan National Guidelines and includes integration of antenatal care, HIV care, and HIV-exposed infant follow up within the maternal-child health clinic through 18-24 months postpartum. Provision of ART, HIV education, and adherence counseling is routinely provided. Psychosocial support is provided by either peer educators or lay health workers. WLWH who miss visits are followed up by phone and then traced in the community to encourage return to care. PWLWH undergo routine VL testing six months after ART initiation or at confirmation of pregnancy if already on ART. VLs are performed every six months through breastfeeding. Women with VL 200 copies/ml undergo enhanced adherence counseling with repeat VL in three months. While routine screening for IPV and depression are recommended per National Guidelines, they are incompletely implemented.
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.
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.
Outcomes
Primary Outcome Measures
Change in the combined retention and treatment failure outcome
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
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.
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.
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.
Fidelity - Coverage
Fidelity coverage will be reached if 80% or more of study participants will complete the expected number of sessions.
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.
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.
Full Information
NCT ID
NCT05841797
First Posted
April 4, 2023
Last Updated
April 21, 2023
Sponsor
University of Colorado, Denver
Collaborators
University of Alabama at Birmingham, Kenya Medical Research Institute, Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT05841797
Brief Title
Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
University of Alabama at Birmingham, Kenya Medical Research Institute, Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants and care providers will not be blinded to study arm, however investigators and analyst will be.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care (SOC)
Arm Type
No Intervention
Arm Description
Standard of Care (SOC): For Arm 1 of the pilot trial, SOC will be implemented. SOC for PWLWH in Kenya is carried out according Kenyan National Guidelines and includes integration of antenatal care, HIV care, and HIV-exposed infant follow up within the maternal-child health clinic through 18-24 months postpartum. Provision of ART, HIV education, and adherence counseling is routinely provided. Psychosocial support is provided by either peer educators or lay health workers. WLWH who miss visits are followed up by phone and then traced in the community to encourage return to care.
PWLWH undergo routine VL testing six months after ART initiation or at confirmation of pregnancy if already on ART. VLs are performed every six months through breastfeeding.
Women with VL 200 copies/ml undergo enhanced adherence counseling with repeat VL in three months. While routine screening for IPV and depression are recommended per National Guidelines, they are incompletely implemented.
Arm Title
In-Person Program Management Plus (PM+)
Arm Type
Experimental
Arm Description
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.
Arm Title
Mobile Program Management Plus (mHealth PM+)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
In-Person Program Management Plus (PM+)
Intervention Description
PM+ sessions conducted via home visits from community mentor mothers
Intervention Type
Behavioral
Intervention Name(s)
Mobile Program Management Plus (mHealth PM+)
Intervention Description
PM+ sessions conducted via phone
Primary Outcome Measure Information:
Title
Change in the combined retention and treatment failure outcome
Description
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.
Time Frame
Baseline, 3 months postpartum, 6 months postpartum
Secondary Outcome Measure Information:
Title
Depression
Description
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.
Time Frame
Baseline, 3 months postpartum, 6 months postpartum
Title
Psychological Outcome Profiles
Description
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.
Time Frame
Baseline, 3 months postpartum, 6 months postpartum
Title
Fidelity - Content
Description
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.
Time Frame
6 months postpartum
Title
Fidelity - Coverage
Description
Fidelity coverage will be reached if 80% or more of study participants will complete the expected number of sessions.
Time Frame
6 months postpartum
Title
Feasibility - Recruitment
Description
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.
Time Frame
Enrollment
Title
Acceptibility
Description
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.
Time Frame
6 months postpartum
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Abuogi, MD, MSc
Phone
303-724-9383
Email
lisa.abuogi@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Abuogi, MD, MSc
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kenya Medical Research Institute
City
Nairobi
Country
Kenya
12. IPD Sharing Statement
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Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya
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