Clinical trial NCT03058484: Community Health Workers and Prevention of Mother-to-Child HIV Transmission in Tanzania
Official title: Short-term Effectiveness of a Community Health Worker Intervention for HIV-infected Pregnant Women in Tanzania to Improve Treatment Adherence and Retention in Care: A Cluster-Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertical Transmission of Infectious Disease
HIV Infections
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Amref Health Africa
name: Ministry of Health and Social Welfare, Tanzania
name: International Initiative for Impact Evaluation
name: Organisation for Public Health Interventions and Development (OPHID)
First posted: 2017-02-23
Enrollment: 1830
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators implemented and evaluated a pilot program in Shinyanga Region, Tanzania to bring prevention of HIV services to communities using community health workers (CHWs). The intervention aimed to integrate community-based maternal and child health services with HIV prevention, treatment, and care-bridging the gap between women and facility, and enhancing the potential benefits of Option B+. Option B+ is the current World Health Organization recommendation for prevention of mother-to-child transmission, but its success in sub-Saharan Africa may be threatened by overburdened clinics and staff. Consequently, paraprofessionals like CHWs can be key partners in the delivery and/or enhancement of health services in the community.

The study focuses on whether this approach: increases retention in care; improves adherence to antiretrovirals (ARVs); or improves the number of women initiating antiretroviral therapy and the timing of initiation. Investigators hypothesize improvements along primary and secondary outcome indicators in the treatment group. This evaluation helps illuminate both the impact and feasibility of the intervention, and the role that CHWs may play in the elimination of mother-to-child transmission services.


Eligibility criteria: Inclusion Criteria:

* Women who were identified in one of the medical registers used for sampling at the facility, were HIV-positive, and had a child born in either the baseline or endline cohort time windows (January and December 2014 or April and October 2015).

Exclusion Criteria:

* Did not have sufficient information to link them across registers

Primary outcomes:
measure: Retention in HIV care
timeFrame: 120 days postpartum
Secondary outcomes:
measure: Adherence to ARVs
timeFrame: Birth to 90 days postpartum
measure: Timing of ART initiation
timeFrame: ART initiation date, expressed as gestational week of pregnancy, up to 40 weeks
measure: Initiation of ART
timeFrame: Through pregnancy and up to 90 days after birth
Other outcomes:
Locations:
Study officials:
References:
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citation: Nance N, Pendo P, Masanja J, Ngilangwa DP, Webb K, Noronha R, McCoy SI. Short-term effectiveness of a community health worker intervention for HIV-infected pregnant women in Tanzania to improve treatment adherence and retention in care: A cluster-randomized trial. PLoS One. 2017 Aug 31;12(8):e0181919. doi: 10.1371/journal.pone.0181919. eCollection 2017.