Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya (Tatua)

University of Colorado Denver (CU Denver)

Status: Active, not recruiting

Conditions: Human Immunodeficiency Virus

Treatments: Behavioral: In-Person Program Management Plus (PM+); Behavioral: Mobile Program Management Plus (mHealth PM+)

Study type: Interventional

Funder types: Other

Identifiers

NCT05841797

22-1946

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Standard of Care (SOC)

No Intervention group

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.

In-Person Program Management Plus (PM+)

Experimental group

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.

Treatment:

Behavioral: In-Person Program Management Plus (PM+)

Mobile Program Management Plus (mHealth PM+)

Experimental group

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.

Treatment:

Behavioral: Mobile Program Management Plus (mHealth PM+)