Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
1080

Summary

Conditions
  • Alcohol Use/Abuse
  • Depression
  • HIV
  • Malnutrition
  • Partner Violence
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 15 years and 49 years
Gender
Only males

Description

Each dollar invested in maternal, child health (MCH) yields a nine-fold benefit. Home visiting has been repeatedly demonstrated efficacious in improving MCH outcomes, including when delivered by CHW in low and middle income countries (LMIC). However, when home visiting programs are scaled, they are ...

Each dollar invested in maternal, child health (MCH) yields a nine-fold benefit. Home visiting has been repeatedly demonstrated efficacious in improving MCH outcomes, including when delivered by CHW in low and middle income countries (LMIC). However, when home visiting programs are scaled, they are not effective. Africa has particular challenges with broad implementation of effective interventions often associated with the poorly trained and poorly monitored health personnel, in this case, CHW who are perinatal home visitors. The investigators have shown that with training, supervision, and accountability, CHW home visits are effective in a successful randomized controlled trial (RCT) conducted in peri-urban townships in Cape Town, South Africa. CHW were trained to address HIV, alcohol, and malnutrition among all pregnant women in a neighborhood - to avoid stigma and to address multiple challenges concurrently. The visits significantly improved maternal and child outcomes over three years. Based on these results, the Philani Intervention Model served as one model for re-engineering primary health care for 65,000 CHW in South Africa. The Mthatha Provincial Government has agreed for the Philani Program to train, monitor, and supervise their already-hired CHW. This RCT will evaluate whether routinely implementing training and monitoring CHW behavior and MCH outcomes with mobile phones, and providing data-informed supervision, will result in CHW becoming more effective. Stellenbosch University interviewers will independently assess outcomes of each mother at pregnancy, and of the mothers and infants within two weeks of post-birth, 6 months, 15 months, and 24 months later. The primary outcome will be maternal HIV/TB testing, linkage to care, treatment adherence and retention in medical regimens, depression, and parenting; and her child's physical growth, cognitive functioning, and behavior adjustment.

Tracking Information

NCT #
NCT02957799
Collaborators
  • National Institute of Mental Health (NIMH)
  • University of Stellenbosch
Investigators
Principal Investigator: Mary Jane Rotheram-Borus Study Principal Investigator Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA