Clinical trial NCT03454373: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: HIV
Food Insecurities
Antiretroviral Therapy
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Ministry of Health and Social Welfare, Tanzania
First posted: 2018-03-05
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The proportion of PLHIV linked to HIV care at 3 months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shinyanga
country: Tanzania
facility: Shinyanga Regional Hospital
state: Shinyanga Region
city: Shinyanga
country: Tanzania
facility: Kambarage Health Center
state: Shinyanga, Region
city: Shinyanga
country: Tanzania
facility: Kahama District Hospital
Study officials:
affiliation: University of California, Berkeley
name: Sandra I McCoy, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: