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General

Study Overview

Title:

The impact of home delivery of antiretroviral therapy on virological suppression: A non-inferiority cluster-randomized controlled trial in Dar es Salaam, Tanzania

Change History for Title

Changed On	Previous Value
08/26/2016	The impact of home delivery of antiretroviral therapy on adherence: A non-inferiority cluster-randomized controlled trial in Dar es Salaam, Tanzania
03/09/2016	The impact of home delivery of antiretroviral therapy on adherence and patients’ healthcare expenditure: a cluster-randomized controlled trial in Dar es Salaam, Tanzania

Study is 3ie funded:

No

Study ID:

RIDIE-STUDY-ID-562a718b12fa0

Initial Registration Date:

10/23/2015

Last Update Date:

03/02/2018

Study Status:

Ongoing

Change History for Status

Changed On	Previous Value
03/09/2016	In Development

Location(s):

Tanzania

Abstract:

Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the potential to reduce key barriers to ART care retention. This trial aims to determine whether ART home-delivery for patients who are clinically stable on ART (combined with facility-based care for those who are not stable) is non-inferior to the standard of care (facility-based care for all). This is a cluster-randomized trial set in Dar es Salaam. The unit of randomization is a healthcare facility with its catchment area. We matched 48 healthcare facilities into pairs based on having a similar number of patients currently on ART (stratified by district). In each pair, one cluster was randomized to the intervention and one to the control arm. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART care and CHW home visits at least every three months without ART home delivery). In addition, within each study arm, half of the healthcare facilities were randomized to enhanced CHW-led nutrition counseling and half to standard counseling.

Change History for Abstract

Changed On	Previous Value
03/02/2018	Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the potential to reduce key barriers to ART care retention. This trial aims to determine whether ART home-delivery for patients who are clinically stable on ART (combined with facility-based care for those who are not stable) is non-inferior to the standard of care (facility-based care for all). This is a cluster-randomized trial set in Dar es Salaam’s Kinondoni and Temeke district. The unit of randomization is a healthcare facility with its catchment area. We matched 34 healthcare facilities into pairs based on having a similar number of patients currently on ART (stratified by district). In each pair, one cluster was randomized to the intervention and one to the control arm. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART care and CHW home visits at least every three months without ART home delivery). In addition, within each study arm, half of the healthcare facilities were randomized to enhanced CHW-led nutrition counseling and half to standard counseling.
08/26/2016	Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the potential to reduce key barriers to ART care retention. The primary endpoint of this trial is the effect of CHW-led home delivery of ART on the proportion of patients with a suppressed HIV viral load after six months follow-up. This is a cluster-randomized controlled trial set in Dar es Salaam’s Temeke district. The unit of randomization is a healthcare facility with its surrounding neighborhoods. We matched all 18 healthcare facilities offering ART services in Temeke district into pairs based on having a similar number of patients currently on ART. In each pair, one cluster was randomized to the intervention and one to the control arm. The intervention consists of monthly home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART care and CHW home visits at least every three months without ART home delivery). In addition, within each study arm, half of the healthcare facilities were randomized to enhanced CHW-led nutrition counseling and half to standard counseling.
03/09/2016	Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the potential to reduce key barriers to ART care retention, particularly the time burden and out-of-pocket expenditures to regularly attend an ART clinic. The primary endpoint of this trial is the effect of CHW-led home delivery of ART on the proportion of patients with a suppressed HIV viral load after six months follow-up. This is a cluster-randomized controlled trial set in Dar es Salaam’s Temeke district. The unit of randomization is a government-owned healthcare facility with its surrounding neighborhoods. We matched 18 healthcare facilities into pairs based on having a similar number of patients currently on ART. In each pair, one cluster was randomized to the intervention and one to the control arm. The intervention consists of monthly home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART care and CHW home visits at least every three months without ART home delivery).

Registration Citation:

Bärnighausen, T. and Geldsetzer, P., 2015. The impact of home delivery of antiretroviral therapy on virological suppression: A non-inferiority cluster-randomized controlled trial in Dar es Salaam, Tanzania. Registry for International Development for Impact Evaluations (RIDIE). Available at: 10.23846/ridie072

Categories:

Health, Nutrition, and Population

Additional Keywords:

antiretroviral therapy, HIV, community health workers, task-shifting, adherence, retention, healthcare expenditure, Tanzania

Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:

Till Bärnighausen

Affiliation:

Harvard T.H. Chan School of Public Health

Name of Second PI:

Pascal Geldsetzer

Affiliation:

Harvard T.H. Chan School of Public Health

Study Sponsor

Name:

International Initiative for Impact Evaluation (3ie)

Study Sponsor Location:

United States

Research Partner

Name of Partner Institution:

Management and Development for Health

Type of Organization:

Research institute/University

Location:

Tanzania

Intervention

Intervention Overview

Intervention:

This trial evaluates two interventions in a two-by-two randomized factorial design. Home delivery of ART: Community health workers (CHWs) visit participants who are clinically stable on ART at home (maintaining the patient's usual clinic visit frequency) to provide counseling (see below), deliver a supply of antiretroviral therapy (ART), and perform an ART pill count. Patients who are not stable on ART receive standard facility-based care. Enhanced nutrition counseling: CHWs provide counseling to all participants in both the intervention and control arms during their home visits. Half of the healthcare facilities in each the intervention and control arm of the trial were randomized to standard counseling, and half to enhanced nutrition counseling. The standard counseling covers family planning, ART adherence, and prevention of HIV transmission. Enhanced nutrition counseling covers advice on 1) food production, 2) a healthy diet for people living with HIV, and 3) exercise.

Change History for Intervention

Changed On	Previous Value
03/02/2018	This trial evaluates two interventions in a two-by-two randomized design. Home delivery of ART: Community health workers (CHWs) visit participants who are clinically stable on ART at home (maintaining the patient's usual clinic visit frequency) to provide counseling (see below), deliver a supply of antiretroviral therapy (ART), and perform an ART pill count. Patients who are not stable on ART receive standard facility-based care. Enhanced nutrition counseling: CHWs provide counseling to all participants in both the intervention and control arms during their home visits. Half of the healthcare facilities in each the intervention and control arm of the trial were randomized to standard counseling, and half to enhanced nutrition counseling. The standard counseling covers family planning, ART adherence, and prevention of HIV transmission. Enhanced nutrition counseling covers advice on 1) food production, 2) a healthy diet for people living with HIV, and 3) exercise.
08/26/2016	This trial evaluates two interventions in a two-by-two randomized design. Home delivery of ART: In intervention clusters, community health workers (CHWs) visit participants at home every four weeks to provide counseling (see below), deliver a one-month’s supply of antiretroviral therapy (ART), and perform an ART pill count. Enhanced nutrition counseling: CHWs provide counseling to all participants in both the intervention and control arms during their home visits. Half of the healthcare facilities in each the intervention and control arm of the trial were randomized to standard counseling, and half to enhanced nutrition counseling. The standard counseling covers family planning, ART adherence, and prevention of HIV transmission. Enhanced nutrition counseling covers advice on 1) food production, 2) a healthy diet for people living with HIV, and 3) exercise. The counseling activities will be carried out at each CHW home visit, which will be monthly in neighborhoods in the study arm randomized to ART home-delivery, and somewhat less frequently (every one to three months) in neighborhoods randomized to facility-based ART care.
03/09/2016	This trial evaluates two interventions in a two-by-two randomized design. Home delivery of ART: In intervention clusters, community health workers (CHWs) visit participants at home every four weeks to provide counseling (see below), deliver a one-month’s supply of antiretroviral therapy (ART), and perform an ART pill count. Nutrition counseling: CHWs provide counseling to all participants in both the intervention and control arms during their home visits. Half (40) of the neighborhoods in each the intervention and control arm of the trial were randomized to standard counseling, and half (39) to standard plus nutrition counseling. The standard counseling covers family planning, ART adherence, and prevention of HIV transmission. Nutrition counseling covers advice on 1) a healthy diet for HIV-infected individuals, 2) boiling or treating water, 3) exercise, and 4) monitoring one’s weight. The counseling activities will be carried out at each CHW home visit, which will be monthly in neighborhoods in the study arm randomized to ART home-delivery, and somewhat less frequently (every one to three months) in neighborhoods randomized to facility-based ART care.

Theory of Change:

Multiple Treatment Arms Evaluated?

Yes

Implementing Agency

Name of Organization:

Management and Development for Health

Type of Organization:

Research Institution/University

Program Funder

Name of Organization:

International Initiative for Impact Evaluation (3ie)

Type of Organization:

NGO (International)

Intervention Timing

Intervention or Program Started at time of Registration?

Yes

Change History for Intervention Timeline

Changed On	Previous Value
03/09/2016	No

Start Date:

02/29/2016

Change History for Start Date

Changed On	Previous Value
03/09/2016	11/16/2015

End Date:

Change History for End Date

Changed On	Previous Value
03/02/2018	11/30/2016
03/09/2016	08/19/2016

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:

This study is a non-inferiority cluster-randomized controlled trial with the unit of randomization being a healthcare facility with its surrounding neighborhoods (mtaa). We selected healthcare facilities providing ART that have an affiliated team of public-sector CHWs. We identified 48 eligible healthcare facilities, and allocated the facility's catchment area to each facility to form a study cluster. Thirdly, stratifying by district, we matched the 48 healthcare facilities into 24 pairs based on having a similar number of patients currently on ART. Lastly, within each pair, we randomly allocated one cluster to the intervention (CHW home visits with ART home-delivery for those stable on ART) and one to the control arm (CHW visits without ART-delivery and standard facility-based care for all ART patients). So, 24 clusters each were randomized to the intervention and control arm. In addition, we randomized half of the healthcare facilities in each study arm to standard counseling, and the other half to standard plus enhanced nutrition counseling during home visits by CHWs.

Change History for Details of Evaluation Approach

Changed On	Previous Value
03/02/2018	This study is a non-inferiority cluster-randomized controlled trial with the unit of randomization being a healthcare facility with its surrounding neighborhoods (mtaa). We selected healthcare facilities providing ART that have an affiliated team of public-sector CHWs. We identified 34 eligible healthcare facilities, and allocated the facility's catchment area to each facility to form a study cluster. Thirdly, stratifying by district, we matched the 34 healthcare facilities into 17 pairs based on having a similar number of patients currently on ART. Lastly, within each pair, we randomly allocated one cluster to the intervention (CHW home visits with ART home-delivery for those stable on ART) and one to the control arm (CHW visits without ART-delivery and standard facility-based care for all ART patients). So, 17 clusters each were randomized to the intervention and control arm. In addition, we randomized half of the healthcare facilities in each study arm to standard counseling, and the other half to standard plus enhanced nutrition counseling during home visits by CHWs.
08/26/2016	This study is a non-inferiority cluster-randomized controlled trial with the unit of randomization being a healthcare facility with its surrounding neighborhoods (mtaa). We selected healthcare facilities providing ART that are located in a neighborhood of Temeke district, in which the home-based carer (henceforth 'CHW') program exists. Secondly, we allocated each CHW with his/her assigned neighborhood to one healthcare facility based on the facility, at which the CHW’s supervisor works. We identified 18 eligible healthcare facilities, and allocated between three and nine neighborhoods to each facility. Thirdly, we matched the 18 healthcare facilities into nine pairs based on having a similar number of patients currently on ART. Lastly, within each pair, we randomly allocated one cluster to the intervention (CHW home visits with ART home-delivery) and one to the control arm (CHW visits without ART-delivery). So, 9 clusters each were randomized to the intervention and control arm. In addition, we randomized half of the healthcare facilities in each study arm to standard counseling, and the other half to standard plus enhanced nutrition counseling during home visits by CHWs.
03/09/2016	This study is a cluster-randomized controlled trial with the unit of randomization being a healthcare facility with its surrounding neighborhoods (mtaa). We selected healthcare facilities providing ART that are located in a neighborhood of Temeke district, in which the home-based carer (henceforth 'CHW') program exists. Secondly, we allocated each CHW with his/her assigned neighborhood to one healthcare facility based on the facility, at which the CHW’s supervisor works. We identified 18 eligible healthcare facilities, and allocated between three and nine neighborhoods to each facility. Thirdly, we matched the 18 clusters into nine pairs based on having a similar number of patients currently on ART at the cluster’s healthcare facility. Lastly, within each pair, we randomly allocated one cluster to the intervention (CHW home visits with ART home-delivery) and one to the control arm (CHW visits without ART-delivery). So, 9 clusters each were randomized to the intervention and control arm. In addition, we randomized half (40) of the neighborhoods in each study arm to only standard counseling, and the other half (39) to standard plus nutrition counseling during home visits by CHWs.

Outcomes (Endpoints):

The primary endpoint for the ART home delivery intervention of this trial is the proportion of all ART patients (regardless of whether they were clinically stable or not at enrollment) who are in viral failure (defined according to Tanzania's HIV treatment guidelines, which currently use a threshold of 1000 copies per milliliter) at the end of the study period. The primary endpoint for the nutrition counseling intervention is the mean BMI of participants who received standard counseling by CHWs versus those who received standard plus enhanced nutrition counseling, assessed at the end of the study period. Secondary endpoints of this trial (all assessed at the end of the study period and all self-reported except for hemoglobin) are: 1) participants’ healthcare expenditures in the last six months, 2) ART adherence during the last one month, 3) proportion of participants producing their own food, 4) diversity of dietary intake, and 5) proportion of patients who are anemic.

Change History for Outcomes (Endpoints)

Changed On	Previous Value
03/02/2018	The primary endpoint for the ART home delivery intervention of this trial is the proportion of all ART patients at a healthcare facility who are virologically suppressed (defined according to Tanzania's HIV treatment guidelines, which currently use a threshold of 100 copies per milliliter) at the end of the study period. The primary endpoint for the nutrition counseling intervention is the mean BMI of participants who received standard counseling by CHWs versus those who received standard plus enhanced nutrition counseling, assessed at the end of the study period. Secondary endpoints of this trial (all assessed at the end of the study period and all self-reported except for hemoglobin) are: 1) participants’ healthcare expenditures in the last six months, 2) ART adherence during the last one month, 3) proportion of participants producing their own food, 4) diversity of dietary intake, and 5) proportion of patients who are anemic.
08/26/2016	The primary endpoint for the ART home delivery intervention of this trial is the proportion of patients who are virologically suppressed (defined according to Tanzania's HIV treatment guidelines, which currently use a threshold of 400 copies per milliliter) six months after study enrolment. The primary endpoint for the nutrition counseling intervention is the mean BMI of participants who received standard counseling by CHWs versus those who received standard plus enhanced nutrition counseling, assessed at six months after study enrolment. Secondary endpoints of this trial (all assessed at six months after enrolment into the trial and all self-reported except for hemoglobin) are: 1) participants’ healthcare expenditures in the last six months, 2) ART adherence during the last one month, 3) proportion of participants producing their own food, 4) diversity of dietary intake, and 5) proportion of patients who are anemic.
03/09/2016	The primary endpoint for the ART home delivery intervention of this trial is the percentage of patients who are virologically suppressed (defined according to Tanzania's HIV treatment guidelines, which currently use a threshold of 400 copies per milliliter) six months after study enrolment. A secondary endpoint is the participants' self-reported healthcare expenditure in the past one month. The primary endpoint for the nutrition counseling intervention is the mean BMI of participants who received standard counseling by CHWs versus those who received standard plus nutrition counseling, assessed at six months after study enrolment.

Unit of Analysis:

A study participant (person)

Hypotheses:

Unit of Intervention or Assignment:

The unit of intervention for both the ART home-delivery intervention and the nutrition counseling intervention is a cluster (a healthcare facility with its catchment area).

Change History for Unit of Intervention or Assignment

Changed On	Previous Value
08/26/2016	The unit of intervention for the ART home-delivery intervention is a cluster. The unit of intervention for the nutrition counseling intervention is a neighborhood (mtaa in KiSwahili).

Number of Clusters in Sample:

48 clusters for both the ART home-delivery and the nutrition intervention

Change History for Number of Clusters in Sample

Changed On	Previous Value
03/02/2018	37 clusters for both the ART home-delivery and the nutrition intervention
08/26/2016	18 clusters for the ART home-delivery intervention; 79 clusters (neighborhoods) for the nutrition counseling intervention.

Number of Individuals in Sample:

2000 participants

Change History for Number of Individuals in Sample

Changed On	Previous Value
08/26/2016	1500 participants
03/09/2016	2500 participants

Size of Treatment, Control, or Comparison Subsamples:

ART home-delivery: 24 clusters in the intervention arm and 24 clusters in the control arm; nutrition counseling intervention: 24 clusters in the intervention arm and 24 clusters in the control arm.

Change History for Size of Treatment, Control, or Comparison Subsamples

Changed On	Previous Value
03/02/2018	ART home-delivery: 17 clusters in the intervention arm and 17 clusters in the control arm; nutrition counseling intervention: 17 clusters in the intervention arm and 17 clusters in the control arm.
08/26/2016	ART home-delivery: 9 clusters in the intervention arm and 9 clusters in the control arm; nutrition counseling intervention: 9 clusters in the intervention arm and 9 clusters in the control arm.
03/09/2016	ART home-delivery: 9 clusters in the intervention arm and 9 clusters in the control arm; nutrition counseling intervention: 39 clusters in the intervention arm and 40 clusters in the control arm.

Supplementary Files

Analysis Plan:

Other Documents:

Data

Outcomes Data

Description:

Participants are enrolled at the healthcare facility and asked to return to the facility at the end of the study period. During each of these two visits, the data collector 1) administers a questionnaire to measure self-reported ART adherence, healthcare expenditures, and dietary intake, 2) measures the participant's viral load (or records the most current viral load if done in the last 12 months), and 3) measures the participant’s height and weight.

Change History for Description

Changed On	Previous Value
08/26/2016	Participants are enrolled at the healthcare facility and asked to return to the facility after six months follow-up. During each of these two visits, the data collector 1) administers a questionnaire to measure self-reported ART adherence, healthcare expenditures, and dietary intake, 2) measures the participant's viral load (or records the most current viral load if done in the last six months), and 3) measures the participant’s height and weight.
03/09/2016	A data collector visits participants at home during the recruitment period and at the end of the six months follow-up period. During each of these two visits, the data collector 1) administers a questionnaire to measure self-reported ART adherence, healthcare expenditures, and dietary intake, 2) takes a blood sample from the participant, which is then sent for measurement of viral load, 3) performs an ART pill count, and 4) measures the participant’s height and weight.

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:

Questionnaire administered at enrolment: Baseline questionnaire.docx
Questionnaire administered to a random sample of HIV patients at ART facilities: Patient exit questionnaire.docx
Questionnaire administered to healthcare providers at the study facilities: Healthcare provider questionnaire.doc

Change History for Upload Study Materials

Changed On	Previous Value
03/09/2016	Description: Questionnaire administered at enrolment Filename: Baseline questionnaire.docx Link: http:// Description: Questionnaire administered to a random sample of HIV patients at ART facilities Filename: Patient exit questionnaire.docx Link: http://
03/09/2016	Description: Questionnaire administered at enrolment Filename: Baseline questionnaire.docx Link: http://

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: