CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,338 enrolled
Drug / intervention
cMM +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02491177
NCT02491177N/ACompleted

Maximizing Adherence and Retention for Women and Infants in the Context of Option B+

University of Colorado, Denver·interventional·Posted Jul 7, 2015·Updated Apr 26, 2021

In Brief

A clinical study evaluating cMM and Text Messaging for Human Immunodeficiency Virus. Completed, enrolled 1,338 participants across 1 site.

Detailed Summary

This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care. The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.

Study Details

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 7, 2015
Enrollment StartMay 1, 2014
Primary CompletionApr 1, 2019
Study CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 11.0 years ago

Interventions

cMMbehavioral

Home visits from community mentor mothers

Text Messagingbehavioral

Text messages received on mobile phone