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Study Overview

Title:
Improving Adherence to Antiretroviral Therapy at Reproductive and Child Health Clinics Integrating Option B+ in Tanzania
Study is 3ie funded:
No
Study ID:
RIDIE-STUDY-ID-55310280d8757
Initial Registration Date:
04/17/2015
Last Update Date:
02/12/2016
Study Status:
In Development
Location(s):
Tanzania
Abstract:

Tanzania adopted Option B+ for HIV-positive pregnant and post-partum women whereby they will receive antiretroviral therapy (ART) at reproductive and child health (RCH) clinics rather than at specialized ART clinics. We hypothesize that the introduction of a minimally invasive, low-cost patient appointment and tracking system in RCH clinics with a mechanism to contact non-attendees, designed using local resources, will improve adherence to appointment keeping and continuity of ART in RCH clinics To test this, we will implement a group-randomized controlled trial in 24 RCH clinics offering treatment to HIV-positive women. Our primary study outcomes will be clinic attendance on the day scheduled in 12 intervention clinics compared to 12 controls. Our evaluation team will review clinic and pharmacy records to extract data on all visits and medication dispensing from 12 months before through 7 months after the intervention for: a) all women (up to of 200 per facility) who were established on treatment for 6 or more months at baseline: and b) up to 5 newly treated patients per facility per month before and after the intervention.

Change History for Abstract
Changed On Previous Value
02/12/2016 Tanzania adopted Option B+ for HIV-positive pregnant and post-partum women whereby they will receive antiretroviral therapy (ART) at reproductive and child health (RCH) clinics rather than at specialized ART clinics. We hypothesize that the introduction of a minimally invasive, low-cost patient appointment and tracking system in RCH clinics with a mechanism to contact non-attendees, designed using local resources, will improve adherence to appointment keeping and continuity of ART in RCH clinics compared to their adherence without the intervention. To test this, we will implement a group-randomized controlled trial in 24 RCH clinics offering treatment to HIV-positive women. Our primary study outcomes will be clinic attendance on the day scheduled in 12 intervention clinics compared to 12 controls. Our evaluation team will review clinic and pharmacy records to extract data on visits and medication dispensing. We will extract data for all women on treatment in each facility (maximum of 200) at baseline, and for the same women during the follow-up assessment. The study period will include 12 months before the beginning of intervention implementation and 7 months after.
Registration Citation:

Chalker, J. and Ross-Degnan, D., 2015. Improving Adherence to Antiretroviral Therapy at Reproductive and Child Health Clinics Integrating Option B+ in Tanzania. Registry for International Development for Impact Evaluations (RIDIE). Available at: 10.23846/ridie048

Categories:
Health, Nutrition, and Population
Additional Keywords:
Adherence, Appointment keeping, Option B+, Antiretroviral therapy, Tanzania,
Secondary ID Number(s):
TW7.17 International Initiative for Impact Evaluation, Inc. (3ie). Thematic Window 7: Integration of HIV Services

Principal Investigator(s)

Name of First PI:
John Chalker
Affiliation:
Management Science for Health (MSH)
Name of Second PI:
Dennis Ross-Degnan
Affiliation:
Harvard Pilgrim Health Care Institute, Drug Policy Research Group, Department of Population Medicine

Study Sponsor

Name:
International Initiative for Impact Evaluation, Inc. (3ie)
Study Sponsor Location:
United States

Research Partner

Name of Partner Institution:
Prevention of Mother-to-Child Transmission (PMTCT) Unit of the Reproductive and Child Health Section of the Ministry of Health and Social Welfare
Type of Organization:
Government agency (eg., statistics office, Ministry of Health)
Location:
Tanzania
Intervention

Intervention Overview

Intervention:

The intervention will comprise two phases focused on 12 RCH facilities (with 12 controls). The team will include representatives from the PMTCT Unit, MSH, and the district health team. For phase 1, we will discuss issues of adherence and retention with the staff in each facility based on baseline survey findings, problems the clinic faces, and local resources available. We will then present the appointment system and demonstrate how to use it. We will either introduce or strengthen a system to contact patients who missed an appointment and help create a feedback loop, so that the facility staff knows the outcome of the contact. Each facility’s contact mechanism will vary according to local resources. We will also teach the staff how to calculate the monthly appointment-keeping indicator (the percentage of patients who arrived for their appointment on or before or within 3 days of the scheduled day) from the appointment system as a means of monitoring how well they are doing. For phase 2, the intervention team will make 4 ongoing assisting and reinforcing supervision visits to each facility at 2, 4, 8, and 12 weeks after the end of phase 1.

Theory of Change:
Multiple Treatment Arms Evaluated?
No

Implementing Agency

Name of Organization:
Management Sciences for Health (MSH)
Type of Organization:
NGO (International)

Program Funder

Name of Organization:
International Initiative for Impact Evaluation, Inc. (3ie)
Type of Organization:
NGO (International)

Intervention Timing

Intervention or Program Started at time of Registration?
No
Start Date:
05/18/2015
End Date:
08/28/2015
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Randomized control trial
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (specify)
Other (not Listed) Method:
Qualitative interviews with key informants to help understand context and observed intervention effects.

Method Details

Details of Evaluation Approach:

This is a group-randomized intervention trial in 24 RCH clinics (12 intervention and 12 control) in Mbeya region to investigate the impact of introducing an appointment system for women on ART and a mechanism to contact those who miss appointments, on rates of missed visits and medication adherence. Contact methods will vary according to local resources. We will conduct a baseline assessment 2 months before the intervention and a follow-up 7 months after. At baseline, we will sample: a) all women (up to 200 per facility) who were established for 6 or more months on treatment; and (b) up to 5 newly treated patients per facility per month. We will extract data on demographic and clinical characteristics and clinic visit details during both assessments. The total study period will be 19 months (12 pre-intervention, 7 post) At baseline, the research team will interview staff in intervention clinics on patient barriers to keeping appointments and adherence; and at follow-up, on staff’s perceptions of the intervention and its effects. Staff in control clinics will be interviewed at follow-up about any recent changes in procedures and any awareness of the interventions.

Change History for Details of Evaluation Approach
Changed On Previous Value
02/12/2016 The study is a group-randomized intervention trial in 24 RCH clinics (12 intervention and 12 control clinics) in Mbeya region to investigate the impact of introducing an appointment system for women on ART and a mechanism to contact those who miss appointments, on rates of missed visits and medication adherence. Contact methods will vary according to local resources. We will conduct a baseline assessment 2 months before the intervention and a follow-up 7 months after. At baseline, we will select all women on treatment in each facility for our study sample (up to 200 per facility); we will extract data on demographic and clinical characteristics and clinic visit details during both assessments. The total study period will be 19 months (12 pre-intervention, 7 post) At baseline, the research team will interview staff in intervention clinics on patient barriers to keeping appointments and adherence; and at follow-up, on staff’s perceptions of the intervention and its effects. Staff in control clinics will be interviewed at follow-up about any changes in procedures in the previous 7 months and whether they had any awareness of the interventions implemented in other districts.
Outcomes (Endpoints):

Our primary outcome is missed clinic visits on the scheduled day, as measured from data in clinic records. Secondary outcomes will include: clinic attendance within 3 days and 7 days of the scheduled date; monthly percentage of days covered by dispensed antiretrovirals; and time until occurrence of a gap in clinic attendance of 15 or more days. We will also include: time until loss to follow-up, which is defined as the average time until a patient has had no clinic contact for 60 days, and retention rates, defined as 100% minus those with no clinic visits within 60 days of a missed appointment. We will use qualitative data from interviews to explore reasons for the intervention’s success or failure.

Unit of Analysis:
Although clinics will be the units of randomization, patients will be the units of analysis. Statistical results will be adjusted for within-clinic and within-patient correlation.
Hypotheses:

To maximize the chances of treatment success and minimize the development of drug resistance, ART programs need to promptly identify and follow-up with patients who miss appointments, which can be accomplished with an easy-to-use, but effective appointment system. Our hypothesis is that introducing an appointment and patient-tracking system coupled with training of staff and follow-up monitoring of patients will improve attendance at RCH clinics that treat women at early stages of HIV infection. We hypothesize that women treated during pregnancy or after delivery will be highly motivated to remain on ART and that the appointment system and contact system for non-attenders, will help them overcome barriers to clinic attendance and medication adherence. We also hypothesize that the appointment system will improve clinic flow and be positively assessed by clinic staff.

Unit of Intervention or Assignment:
The units are RCH clinics in Mbeya with more than 75 women on ART.
Number of Clusters in Sample:
12 intervention and 12 control facilities within four pairs of districts.
Number of Individuals in Sample:
Approximately 1500 women per study arm (average of 125 per facility)
Size of Treatment, Control, or Comparison Subsamples:
12 clinics per study arm, each with an average of 125 women making approximately 19 clinic visits per woman (approximately 1500 women and approximately 28,500 visits per study arm)

Supplementary Files

Analysis Plan:
TW7.17 Analysis Plan 2.docx
Other Documents:
Data

Outcomes Data

Description:
This is a health facility survey with data from clinic and pharmacy records, on visits (visit date, purpose, and date of next visit) and medication dispensing (antiretroviral type, amount, days’ supply). The baseline will include all women on ART in each facility (up to 200); with data for these women also extracted during the follow-up assessment. In total, the study period will include 12 months before the beginning of intervention implementation and 7 months after implementation.
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:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
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:
Data Collection Completion Date:
Unit of Analysis:
Clusters in Final Sample:
Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

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

Study Stopped

Date:
Reason: