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

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ClinicalTrials.gov Identifier: NCT03454373
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Ministry of Health and Social Welfare, Tanzania
Information provided by (Responsible Party):
Sandra McCoy, University of California, Berkeley

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.

Condition or disease Intervention/treatment Phase
Hiv Behavioral: Incentive for linkage to care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Incentive for return to care
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.
Behavioral: Incentive for linkage to care
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

No Intervention: Comparator
Standard of care HIV primary care services, including counseling to return to care.



Primary Outcome Measures :
  1. The proportion of PLHIV linked to HIV care at 3 months [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454373


Contacts
Contact: Sandra I McCoy, MPH, PhD 510-642-0534 smccoy@berkeley.edu
Contact: Prosper F Njau, MD prosperpendo@gmail.com

Locations
Tanzania
Shinyanga Regional Hospital Recruiting
Shinyanga, Shinyanga Region, Tanzania
Contact: Sandra I McCoy, MPH, PhD    510-642-0534    smccoy@berkeley.edu   
Contact: Prosper Njau, MD       prosperpendo@gmail.com   
Kambarage Health Center Recruiting
Shinyanga, Shinyanga, Region, Tanzania
Contact: Sandra I McCoy, MPH, PhD    510-642-0534    smccoy@berkeley.edu   
Contact: Prosper Njau, MD       prosperpendo@gmail.com   
Kahama District Hospital Recruiting
Shinyanga, Tanzania
Contact: Sandra I McCoy, MPH, PhD    510-642-0534    smccoy@berkeley.edu   
Contact: Prosper Njau, MD       prosperpendo@gmail.com   
Sponsors and Collaborators
University of California, Berkeley
National Institute of Mental Health (NIMH)
Ministry of Health and Social Welfare, Tanzania
Investigators
Principal Investigator: Sandra I McCoy, MPH, PhD University of California, Berkeley

Responsible Party: Sandra McCoy, Assistant Adjunct Professor, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT03454373     History of Changes
Other Study ID Numbers: 2017-11-10508
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandra McCoy, University of California, Berkeley:
HIV
Food Insecurities
Antiretroviral Therapy