ClinicalTrials.gg
CompletedNCT03351556Updated Aug 22, 2022

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

An interventional study of Active Arm 1 and Active Arm 2 in HIV/AIDS, Adherence, Medication and Adherence, Patient, sponsored by University of California, Berkeley. Completed at 4 sites in Tanzania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-22.

Sponsored by University of California, Berkeley · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
530
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

  1. Determine the "dose-response" relationship between a cash transfer amount and HIV viral suppression at 6 months
  2. Identify the most effective cash transfer size to increase the proportion of people living with HIV infection (PLHIV) retained in care and with suppressed viral load (\<1000 copies/ml) after 6 months. (This amount will be further evaluated in a cluster randomized trial in Phase 2).
Read the detailed description

Participants in the control group will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS.

The study has two active intervention arms:

  1. The opportunity to earn 10,000 TZS/month (\~$4.50) for up to 6 months conditional on visit attendance, and
  2. The opportunity to earn 22,500 TZS/month (\~$10.00) for up to 6 months conditional on visit attendance

In both intervention arms, cash transfers will be delivered a maximum of once monthly, spaced ≥28 days apart, for up to six months and delivered via an automatic mobile money system linked to a biometric identification system.

02

Conditions studied

  • HIV/AIDS
  • Adherence, Medication
  • Adherence, Patient
03

In context

Acquired Immunodeficiency Syndrome

3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.

This study's enrollment of 530 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

University of California, Berkeley is the lead sponsor of 111 studies on the registry; 20 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥18 years
  • Living with infection
  • Initiated antiretroviral therapy ≤1 month prior to enrollment in the study

Exclusion criteria

Exclusion Criteria:

  • Participants who do no provide
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
530 participants (actual)

Study arms

  • No intervention
    Comparison Arm

    Participants in the comparison group will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS.

  • Experimental
    Active Intervention 1

    Participants will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 10,000 TZS/month (\~$4.50) for up to 6 months conditional on visit attendance.

    Behavioral: Active Arm 1

  • Experimental
    Active Intervention 2

    Participants will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 22,500 TZS/month (\~$10.00) for up to 6 months conditional on visit attendance.

    Behavioral: Active Arm 2

Interventions

  • BehavioralActive Arm 1

    Participants in this arm will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 10,000 TZS/month conditional on visit attendance.

  • BehavioralActive Arm 2

    Participants in this arm will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 22,500 TZS/month conditional on visit attendance.

06

What researchers measure

Primary outcomes

  1. HIV viral suppression at 6 months

    \<1000 copies/ml

    Time frame: 6 months

07

Study locations

4 sites
  • Kahama Hospital
    Kahama, Shinyanga Region, Tanzania
  • Kagongwa Health Center
    Shinyanga, Shinyanga Region, Tanzania
  • Kambarage Health Center
    Shinyanga, Shinyanga Region, Tanzania
  • Shinyanga Regional Referral Hospital
    Shinyanga, Shinyanga Region, Tanzania
08

References and documents

Publications

  • Packel L, Fahey C, Kalinjila A, Mnyippembe A, Njau P, McCoy SI. Preparing a financial incentive program to improve retention in HIV care and viral suppression for scale: using an implementation science framework to evaluate an mHealth system in Tanzania. Implement Sci Commun. 2021 Sep 23;2(1):109. doi: 10.1186/s43058-021-00214-w. PubMed 34556176 ↗
  • Fahey CA, Njau PF, Katabaro E, Mfaume RS, Ulenga N, Mwenda N, Bradshaw PT, Dow WH, Padian NS, Jewell NP, McCoy SI. Financial incentives to promote retention in care and viral suppression in adults with HIV initiating antiretroviral therapy in Tanzania: a three-arm randomised controlled trial. Lancet HIV. 2020 Nov;7(11):e762-e771. doi: 10.1016/S2352-3018(20)30230-7. Epub 2020 Sep 3. PubMed 32891234 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Jun 2019, 14 months.

Of 641 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 14 months is below that.

Counting every sponsor, half of 647 studies reached it within 29 months; a quarter within 17 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2017
First posted
Nov 24, 2017
StartActual
Apr 24, 2018
Primary completionActual
Jun 30, 2019
CompletionActual
Jun 30, 2019
Last update
Aug 22, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03351556
Collaborators
National Institute of Mental Health (NIMH), Rasello, Health for a Prosperous Nation, Management and Development for Health in Tanzania
Responsible party
Sandra McCoy (PI, University of California, Berkeley) — Principal investigator
First posted
Nov 24, 2017
Start date
Apr 24, 2018
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Aug 22, 2022

Study contacts

Sandra I McCoy, PhD
principal investigator · University of California, Berkeley
Prosper Njau, MD, MPH
principal investigator · Health for a Prosperous Nation and Ministry of Health, Community Development, Gender, Elderly, and Children

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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