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

NCT03454373 | Completed

• 1 other identifier: 2017-11-10508
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 3

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.

Conditions

Hiv

Keywords

HIV; Food Insecurities; Antiretroviral Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

Incentive for return to care

EXPERIMENTAL

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

Comparator

NO INTERVENTION

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

Interventions

Incentive for linkage to care BEHAVIORAL

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

Incentive for return to care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- None

Sponsors & Collaborators

• University of California, Berkeley: lead
• National Institute of Mental Health (NIMH): collaborator
• Ministry of Health and Social Welfare, Tanzania: collaborator

Study Sites (3)

Kambarage Health Center

Shinyanga, Shinyanga, Tanzania

Location

Shinyanga Regional Hospital

Shinyanga, Shinyanga, Tanzania

Location

Kahama District Hospital

Shinyanga, Tanzania

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sandra I McCoy, MPH, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Adjunct Professor

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: March 5, 2018
• Study Start: March 1, 2018
• Primary Completion: September 12, 2019
• Study Completion: October 1, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

TA (3)