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Human Immunodeficiency VirusTatuaNCT05841797

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

A study testing In-Person Program Management Plus (PM+) and Mobile Program Management Plus (mHealth PM+) in people with Human Immunodeficiency Virus, run by University of Colorado, Denver at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
In-Person Program Management Plus (PM+) and Mobile Program Management Plus (mHealth PM+)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteKenya
Study dates
5 Jun 2023to 12 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Kenya Medical Research Institute

    Nairobi

Other trials in Kenya

About this study

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

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.

Read the 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.

Being tested
In-Person Program Management Plus (PM+), Mobile Program Management Plus (mHealth PM+)
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
Medical subject headings
Acquired Immunodeficiency Syndrome, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-Person Program Management Plus (PM+)Behavioural

    PM+ sessions conducted in-person by mentor mothers

  • Mobile Program Management Plus (mHealth PM+)Behavioural

    PM+ sessions conducted via phone

Study groups in NCT05841797
Study groupRoleWhat they receive
Standard of Care (SOC)No interventionStandard 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.
In-Person Program Management Plus (PM+)ExperimentalFor 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.
Receives: Behavioral: In-Person Program Management Plus (PM+)
Mobile Program Management Plus (mHealth PM+)ExperimentalFor 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.
Receives: Behavioral: Mobile Program Management Plus (mHealth PM+)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined retention and treatment failure outcome

    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.

    Measured: Baseline, 3 months postpartum, 6 months postpartum

Secondary outcomes (6)

  1. 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.

    Measured: Baseline, 3 months postpartum, 6 months postpartum

  2. 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.

    Measured: Baseline, 3 months postpartum, 6 months postpartum

  3. 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.

    Measured: 6 months postpartum

  4. Fidelity - Coverage

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

    Measured: 6 months postpartum

  5. 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.

    Measured: Enrollment

  6. 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.

    Measured: 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start5 Jun 2023
  3. Primary completion12 Aug 2025
  4. Study completion12 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05841797
Sponsor's protocol ID
22-1946
Acronym
Tatua
Status last verified
Dec 2025
First submitted
4 Apr 2023
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Helova A, Onono M, Ogolla-Onyando M, Ouma E, Imran R, Beres LK, Hampanda K, Owuor K, Szychowski JM, Ongeri L, Abuogi LL, Turan JM. Evaluation of risk stratification and problem management plus (PM+) for pregnant women with HIV in Kenya (Tatua study): Protocol paper. Contemp Clin Trials. 2025 Apr;151:107838. doi: 10.1016/j.cct.2025.107838. Epub 2025 Feb 6.

    PubMed 39921155

Questions about this trial

What is this clinical trial studying?

A study testing In-Person Program Management Plus (PM+) and Mobile Program Management Plus (mHealth PM+) in people with Human Immunodeficiency Virus, run by University of Colorado, Denver at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined retention and treatment failure outcome (time frame: Baseline, 3 months postpartum, 6 months postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05841797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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