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

• Sponsor: University of California, Berkeley (Other)
• Overall Status: Completed
• CT.gov ID: NCT03454373
• Collaborator: National Institute of Mental Health (NIMH) (NIH), Ministry of Health and Social Welfare, Tanzania (Other)
• Enrollment: 800
• Locations: 3
• Arms: 2
• Actual Duration (Months): 31
• Patients Per Site: 266.7
• Patients Per Site Per Month: 8.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hiv	Behavioral: Incentive for linkage to care	N/A

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 Design

• Study Type: Interventional
• Actual 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: Mar 1, 2018
• Actual Primary Completion Date: Sep 12, 2019
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The proportion of PLHIV linked to HIV care at 3 months [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shinyanga Regional Hospital	Shinyanga	Shinyanga Region	Tanzania
2	Kambarage Health Center	Shinyanga	Shinyanga, Region	Tanzania
3	Kahama District Hospital	Shinyanga		Tanzania

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sandra McCoy, Assistant Adjunct Professor, University of California, Berkeley
• ClinicalTrials.gov Identifier: NCT03454373
• Other Study ID Numbers: 2017-11-10508
• First Posted: Mar 5, 2018
• Last Update Posted: Nov 20, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sandra McCoy, Assistant Adjunct Professor, University of California, Berkeley: HIV; Food Insecurities; Antiretroviral Therapy
• Additional relevant MeSH terms: HIV Seropositivity

Study Results

No Results Posted as of Nov 20, 2020