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

NCT05841797

CompletedNA

Sponsor: University of Colorado, Denver

Conditions: Human Immunodeficiency Virus

Interventions: In-Person Program Management Plus (PM+), Mobile Program Management Plus (mHealth PM+)

Countries: 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.

Eligibility overview

Sex: ALL

Age: 15 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (1)
  • Nairobi, Kenya