CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 800 enrolled
Drug / intervention
NAC (Nutritional Assessment and Counseling) +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01957917
NCT01957917N/ACompleted

Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania

University of California, Berkeley·interventional·Posted Oct 8, 2013·Updated Mar 31, 2020

In Brief

A clinical study evaluating NAC (Nutritional Assessment and Counseling), Cash Transfer, and 1 other intervention for HIV. Completed, enrolled 800 participants across 4 sites.

Detailed Summary

The importance of good nutrition and food security among people living with HIV infection (PLHIV) is widely recognized. In resource-constrained settings, food insecurity is increasingly recognized as an important barrier to retention in care and adherence to antiretroviral therapy (ART). However, there are few studies demonstrating that food and nutrition assistance programs can improve HIV-related outcomes. This study will address this gap by comparing the effectiveness of three models for short-term support for PLHIV. Food insecure women and men on ART will be randomized into one of three groups: 1) nutrition assessment and counseling (NAC) alone, 2) NAC plus food assistance, or 3) NAC plus cash transfers. The investigators will compare the effect of the three approaches on ART adherence and retention in care after 6, 12, and 24-36 months of follow-up. The investigators hypothesize that NAC plus short-term support in the form of food or cash assistance will result in better adherence to ART and retention in care than NAC alone, and that the effects of NAC plus food assistance will be the same as NAC plus cash assistance. The results from the study will provide evidence about which assistance modalities for PLHIV work best to improve ART adherence and retention in care, and under what conditions. This study will be conducted in Shinyanga Region, Tanzania, where approximately 17 percent of households have poor or borderline food consumption and 7.4 percent of people are living with HIV infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesTanzania

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 8, 2013
Enrollment StartDec 1, 2013
Primary CompletionOct 1, 2016
Study CompletionSep 12, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.7 years ago

Interventions

NAC (Nutritional Assessment and Counseling)other

Cash Transferother

Food Assistanceother