- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05841797
Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya (Tatua)
Piloting Risk Stratification and Tailored Interventions With Pregnant and Postpartum Women With HIV in Kenya to Prevent Disengagement From Care and Viral Failure
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lisa Abuogi, MD, MSc
- Phone Number: 303-724-9383
- Email: lisa.abuogi@cuanschutz.edu
Study Locations
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Nairobi, Kenya
- Kenya Medical Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care (SOC)
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. |
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Experimental: 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.
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PM+ sessions conducted via home visits from community mentor mothers
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Experimental: 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.
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PM+ sessions conducted via phone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the combined retention and treatment failure outcome
Time Frame: Baseline, 3 months postpartum, 6 months postpartum
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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.
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Baseline, 3 months postpartum, 6 months postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: Baseline, 3 months postpartum, 6 months postpartum
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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.
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Baseline, 3 months postpartum, 6 months postpartum
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Psychological Outcome Profiles
Time Frame: Baseline, 3 months postpartum, 6 months postpartum
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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.
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Baseline, 3 months postpartum, 6 months postpartum
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Fidelity - Content
Time Frame: 6 months postpartum
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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.
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6 months postpartum
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Fidelity - Coverage
Time Frame: 6 months postpartum
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Fidelity coverage will be reached if 80% or more of study participants will complete the expected number of sessions.
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6 months postpartum
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Feasibility - Recruitment
Time Frame: Enrollment
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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.
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Enrollment
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Acceptibility
Time Frame: 6 months postpartum
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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.
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6 months postpartum
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa Abuogi, MD, MSc, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Mental health
- Retention in care
- Infant Health
- Linkage to care
- Vertical transmission
- Mobile intervention
- Early infant diagnosis
- HIV Transmission
- Antiretroviral therapy adherence
- Prevention of Mother to Child Transmission
- Community Mentor Mothers
- Maternal CD4/viral loads
- Acceptability of interventions
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 22-1946
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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