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Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania

Primary Purpose

Hiv

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Incentive for linkage to care
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hiv focused on measuring HIV, Food Insecurities, Antiretroviral Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Study participant in the prior study "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania" (NCT01957917)
  • Alive and willing to provide written informed consent
  • Not currently enrolled in HIV care services

Exclusion Criteria:

- None

Sites / Locations

  • Shinyanga Regional Hospital
  • Kambarage Health Center
  • Kahama District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Incentive for return to care

Comparator

Arm Description

Standard of care HIV primary care services, including counseling to return to care, plus a one-time "re-start" incentive of 22,500 TZS to return to care.

Standard of care HIV primary care services, including counseling to return to care.

Outcomes

Primary Outcome Measures

The proportion of PLHIV linked to HIV care at 3 months
Initial re-engagement in care, defined as as the proportion of PLHIV who have completed (attended) a HIV primary care visit at the clinic of the PLHIV's choosing within 3 months of the incentive offer to return to care.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2018
Last Updated
November 19, 2020
Sponsor
University of California, Berkeley
Collaborators
National Institute of Mental Health (NIMH), Ministry of Health and Social Welfare, Tanzania
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1. Study Identification

Unique Protocol Identification Number
NCT03454373
Brief Title
Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
Official Title
Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 12, 2019 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Berkeley
Collaborators
National Institute of Mental Health (NIMH), Ministry of Health and Social Welfare, Tanzania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This protocol is for the long term follow-up study of "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy (ART) in Tanzania", a 3-arm randomized controlled trial led by Professor Sandra McCoy at the University of California Berkeley and Dr. Prosper Njau at the Tanzanian Ministry of Health and Social Welfare. The investigators will determine the long-term effectiveness of short-term incentives for ART adherence and retention in care. The study will also determine whether incentives can also be used to re-engage PLHIV with HIV care after they have fallen out of care.
Detailed Description
This study will build on preliminary data from a randomized study conducted in Shinyanga, Tanzania which found that short-term cash and food assistance improved ART adherence and retention in care among food insecure people living with HIV infection (PLHIV) after 6 and 12 months of follow-up. The investigators will now determine the long-term effectiveness of these incentive strategies. In this 2-year study, investigators will first determine 24-month adherence and retention outcomes using medical and pharmacy records for the 781 PLHIV who were alive at the end of the previous study, which concluded after 12 months of follow-up (Aim 1). Then, leveraging an existing program of home based care, investigators will determine the prevalence of undocumented transfers and deaths among the subset of patients found to be lost to follow-up or transferred in clinic records. Investigators will use these data from home visits to adjust estimates of the interventions' effectiveness on retention in HIV care and mortality (Aim 2). Among the PLHIV found to be disengaged from care, investigators will conduct a pilot study of a one-time cash incentive to encourage PLHIV to re-engage with care, with the goal of mitigating the barriers posed by transportation and opportunity costs (Aim 3). At the conclusion of the project, investigators will understand the long-term effectiveness of cash and food incentives for adherence and retention, and whether they can also be used for re-linking PLHIV to care, data highly relevant to 'Treat All' programs in Fast Track countries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv
Keywords
HIV, Food Insecurities, Antiretroviral Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incentive for return to care
Arm Type
Experimental
Arm Description
Standard of care HIV primary care services, including counseling to return to care, plus a one-time "re-start" incentive of 22,500 TZS to return to care.
Arm Title
Comparator
Arm Type
No Intervention
Arm Description
Standard of care HIV primary care services, including counseling to return to care.
Intervention Type
Behavioral
Intervention Name(s)
Incentive for linkage to care
Intervention Description
Participants who were found to have been lost to care will receive standard of care plus a one-time "re-start" incentive of 22,500 TZS to return to care
Primary Outcome Measure Information:
Title
The proportion of PLHIV linked to HIV care at 3 months
Description
Initial re-engagement in care, defined as as the proportion of PLHIV who have completed (attended) a HIV primary care visit at the clinic of the PLHIV's choosing within 3 months of the incentive offer to return to care.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Study participant in the prior study "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania" (NCT01957917) Alive and willing to provide written informed consent Not currently enrolled in HIV care services Exclusion Criteria: - None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra I McCoy, MPH, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shinyanga Regional Hospital
City
Shinyanga
State/Province
Shinyanga Region
Country
Tanzania
Facility Name
Kambarage Health Center
City
Shinyanga
State/Province
Shinyanga, Region
Country
Tanzania
Facility Name
Kahama District Hospital
City
Shinyanga
Country
Tanzania

12. IPD Sharing Statement

Learn more about this trial

Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania

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