Skip to main content
OpenTrials
Completed

NCT Number: NCT04201353

Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy Phase II

This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 12 months post-ART initiation among PHWHIV who have initiated ART within the past 30 days. Randomization will take place at the clinic level (HIV primary care clinics), and eligible participants attending intervention clinics will have the opportunity to receive up to 6 consecutive monthly cash transfers of 22,500 TSH (~$10) each, conditional on visit attendance with the HIV care provider. The study will take place at 32 clinics across four regions in Tanzania: Gaeta, Mwanza, Kagera and Shinyanga. The primary endpoint is viral suppression at 12 months, defined as the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV (Human Immunodeficiency Virus) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health for a Prosperous Nation (HPON)

Dar es Salaam, Tanzania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Greater than or equal to 18 years of age
  • Living with HIV infection
  • Initiated on antiretroviral therapy less than or equal to 1 month prior to enrollment in the study
  • Have access to a mobile phone (ownership, shared ownership, or access to a trusted person's phone)
  • Do not intend to transfer to a different facility for HIV care within the following 12 months.

Exclusion criteria

-

Treatment and study plan

Conditional cash transfer

Behavioral

The intervention is a monthly cash transfer of 22,500 Tanzanian Shillings (~$10) for up to 6 months conditional on visit attendance.

Primary outcomes

  1. 12-month Viral Suppression

    Time frame: 12 months

    the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART. The primary outcome is expressed as a binary variable, defined as PLHIV who are on ART and with sufficient HIV viral suppression (<1000 copies/ml, WHO's threshold for virologic failure in LMICs) versus not on ART or viral failure (≥1000 copies/ml).

Secondary outcomes

  1. Appointment Attendance

    Time frame: 12 months

    The proportion of scheduled visits that were completed during the 0-12 month period

  2. 6-month Viral Suppression

    Time frame: 6 month

    the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART. The primary outcome is expressed as a binary variable, defined as PLHIV who are on ART and with sufficient HIV viral suppression (<1000 copies/ml, WHO's threshold for virologic failure in LMICs) versus not on ART or viral failure (≥1000 copies/ml).

  3. Proportion Virally Suppressed

    Time frame: 12 months

    • The proportion virally suppressed (<1000 copies/ml) of those PLHIV with a viral load result

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • Health for a Prosperous Nation
  • Rasello
  • Tanzania Ministry of Health, Community Development, Gender, Elderly and Children

Registry information

Official study title

Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy, Phase II: Effectiveness Study

Acronym: Afya 2 Phase2

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Dec 17, 2019
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.