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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03454373
Enrollment
800
Registered
2018-03-05
Start date
2018-03-01
Completion date
2020-10-01
Last updated
2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

Keywords

HIV, Food Insecurities, Antiretroviral Therapy

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.

Interventions

BEHAVIORALIncentive 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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Ministry of Health and Social Welfare, Tanzania
CollaboratorOTHER_GOV
University of California, Berkeley
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
The proportion of PLHIV linked to HIV care at 3 months3 monthsInitial 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.

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026