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Study Overview

Title:
Integration of Community MNCH Services with PMTCT using Community Health Workers to Enhance Retention in Care and Improve Adherence to Antiretroviral Therapy in Tanzania
Study is 3ie funded:
No
Study ID:
RIDIE-STUDY-ID-552553838b402
Initial Registration Date:
04/08/2015
Last Update Date:
07/13/2018
Study Status:
Completed
Change History for Status
Changed On Previous Value
07/13/2018 Ongoing
Location(s):
Tanzania
Abstract:
The integration of HIV care and treatment with maternal, newborn, and child health (MNCH) services is essential for prevention of mother-to-child HIV transmission (PMTCT) and for the health of HIV-infected pregnant and postpartum women. However, there is a paucity of evidence on the effect of integrating MNCH and PMTCT services using community health workers (CHWs). To address this gap, we will evaluate a pilot program in Shinyanga Region, Tanzania to integrate MNCH and PMTCT services using CHWs. The multi-pronged intervention includes: 1) linkage of CHWs to reproductive and child health (RCH) clinics; 2) distribution of the “Action Birth Card”, an interactive birth planning tool; 3) adherence counseling for HIV-infected women; and 4) tracing of HIV-infected pregnant women who are lost to follow-up. We hypothesize that these strategies will newly integrate community-based MNCH services with HIV prevention, treatment, and care. In a cluster-randomized study, we will evaluate whether this approach: 1) results in earlier initiation of HIV treatment; 2) increases the proportion of HIV-infected pregnant women who are retained in care; and 3) increases adherence to treatment.
Registration Citation:
Categories:
Health, Nutrition, and Population
Additional Keywords:
HIV, community health workers, PMTCT, adherence, integration
Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:
Sandra I. McCoy
Affiliation:
University of California, Berkeley
Name of Second PI:
Rita Noronha
Affiliation:
Amref Health Africa Tanzania

Study Sponsor

Name:
3ie
Study Sponsor Location:

Research Partner

Name of Partner Institution:
Amref Health Africa Tanzania
Type of Organization:
NGO-international
Location:
Tanzania
Intervention

Intervention Overview

Intervention:
The intervention, Mama na Mtoto Pamoja (Mother & Child Together), includes the following activities: 1. Linkage of existing CHWs to reproductive and child health (RCH) clinics: Each CHW will participate in monthly meetings with a RCH nurse to discuss activities, receive mentorship, and determine which women have been lost to follow-up. 2. Action Birth Card: The “Action Birth Card” is an interactive planning tool for women distributed by CHWs that asks pregnant and postpartum women to define and overcome barriers to health services. The card facilitates discussion between CHWs and their clients and serves as a user-friendly record of completed services kept by and used by women in the community. 3. Tracing treatment defaulters: CHWs will identify women who are lost to follow-up and will attempt to contact these women via mobile phone or home visit and re-engage them in care. CHWs will provide updates to the clinic about their progress and will coordinate tracing activities. 4. Adherence counseling for HIV-infected women: CHWs will conduct adherence counseling at monthly home visits with HIV-infected women, with additional messaging customized for asymptomatic women.
Private Intervention Details:
Theory of Change:
Multiple Treatment Arms Evaluated?
No

Implementing Agency

Name of Organization:
Amref Health Africa Tanzania
Type of Organization:
NGO (International)

Program Funder

Name of Organization:
3ie
Type of Organization:
NGO (International)

Intervention Timing

Intervention or Program Started at time of Registration?
No
Start Date:
04/13/2015
End Date:
12/31/2015
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Randomized control trial
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:
The impact evaluation will evaluate the effect of the intervention using a cluster randomized controlled trial. We will allocate 30 rural and semi-urban health facility service areas (“communities”) to the treatment or comparison condition and measure the community-level outcomes at baseline (0 months) and end line (9 months) using routinely collected data from community health workers and health facility medical registers. We will determine the impact of the intervention on the primary outcomes of antiretroviral therapy (ART) initiation, retention in care, and adherence to ART. We will determine whether the effect of the intervention is strongest among women who received the most visits from CHWs (among those in the intervention communities), compared to women living in comparison communities. We will also conduct a mixed methods process evaluation with the primary stakeholders, including but not limited to, CHWs, clinic staff, and pregnant and postpartum women, to assess intervention: 1) acceptability; 2) feasibility; and 3) potential spillover benefits on other outcomes.
Private Details of Evaluation Approach:
Outcomes (Endpoints):
Primary Outcomes: 1. ART initiation timing: The timing of ART initiation among HIV-infected pregnant women according to gestational week. 2. Retention in care: Whether an HIV-infected pregnant or postpartum woman on ART is still in care 90 days postpartum. 3. Adherence: We will measure adherence with the medication possession ratio (MPR), the proportion of days when ART was prescribed and an individual is in possession of ART (determined with pharmacy dispensing data). MPR is associated with short-term virologic outcomes. We will determine the proportion of women with MPR greater than or equal to 95% at 90 days postpartum.
Unit of Analysis:
Health facility service area (community)
Hypotheses:
We hypothesize that the new integration of community-based MNCH services with PMTCT using CHWs will increase demand for HIV treatment among HIV-infected pregnant and breastfeeding women and will improve retention in care and adherence to antiretroviral treatment.
Unit of Intervention or Assignment:
Health facility service area (community)
Number of Clusters in Sample:
30
Number of Individuals in Sample:
1170 (both arms combined)
Size of Treatment, Control, or Comparison Subsamples:
15 treatment communities, 15 comparison communities

Supplementary Files

Analysis Plan:
Other Documents:
Data

Outcomes Data

Description:
The impact evaluation will primarily use data from two sources: 1) community health worker visit frequency data, recorded in CHW logs; and 2) medical record data for individual women collected from various health facility registers at reproductive and child health clinics and HIV treatment clinics.
Data Already Collected?
No
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Treatment Assignment Data

Participation or Assignment Information:
No
Description:
Communities were randomly assigned to treatment by the impact evaluation team; thus, treatment assignment is known.
Data Obtained by the Study Researchers?
Yes
Data Previously Used?
No
Data Access:
Not restricted - access with no requirements or minimal requirements (e.g. web registration)
Data Obtained by the Study Researchers?
Yes
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
Completion

Completion Overview

Intervention Completion Date:
06/01/2017
Data Collection Completion Date:
12/31/2016
Unit of Analysis:
Cluster
Clusters in Final Sample:
32
Total Observations in Final Sample:
1152
Size of Treatment, Control, or Comparison Subsamples:
15,17

Findings

Preliminary Report:
Yes
Preliminary Report URL:
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0181919
Summary of Findings:
Intervention and comparison facilities were similar at baseline. Data were collected from 1,152 and 678 mother-infant pairs at baseline and endline, respectively. There were no significant differences in retention in care, ART initiation, or timing of ART initiation between the intervention and control groups. Adherence (MPR?95%) at 90 days postpartum was 11.3 percentage points higher in the intervention group in ITT analyses (95% CI: -0.7, 23.3, p = 0.06), though this effect was attenuated after adjusting for baseline imbalance (9.5 percentage points, 95% CI: -2.9, 22.0, p = 0.13). Among only sites that had the greatest fidelity to the intervention, however, we found a stronger effect on adherence (13.6 percentage points, 95% CI: 2.5, 24.6).
Paper:
Yes
Paper Summary:
Nance N, Pendo P, Masanja J, Ngilangwa DP, Webb K, Noronha R, et al. (2017) 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 12(8): e0181919. https://doi.org/10.1371/journal.pone.0181919
Paper Citation:
Nance N, Pendo P, Masanja J, Ngilangwa DP, Webb K, Noronha R, et al. (2017) 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 12(8): e0181919. https://doi.org/10.1371/journal.pone.0181919

Data Availability

Data Availability (Primary Data):
Yes--Available now
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Yes
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: