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CompletedNCT04201353Afya 2 Phase2Updated Aug 19, 2024

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

An interventional study of Conditional Cash Transfer in HIV (Human Immunodeficiency Virus), sponsored by University of California, Berkeley. Completed at 1 site in Tanzania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by University of California, Berkeley · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,984
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • HIV (Human Immunodeficiency Virus)

Keywords

  • Antiretroviral Treatment Adherence
  • Conditional Cash Transfers
  • Tanzania
  • People Living With HIV
  • Behavioral Economics
03

In context

Acquired Immunodeficiency Syndrome

2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.

This study's enrollment of 1,984 is above the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

University of California, Berkeley is the lead sponsor of 110 studies on the registry; 19 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
Yes

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

  • 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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
1,984 participants (actual)

Study arms

  • Experimental
    Conditional Cash Transfer

    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. Cash transfers will be given once monthly for up to 6 months, spaced ≥25 days apart (consistent with National Guidelines for monthly or bimonthly visits) and are conditional on visit attendance. This means that the cash transfer is only given when the patient visits the clinic for their routine appointment, regardless of whether the visit is earlier or later than the scheduled appointment.

    Behavioral: Conditional Cash Transfer

  • No intervention
    Control

    Participants attending control clinics will receive the standard of care.

Interventions

  • BehavioralConditional Cash Transfer

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

06

What researchers measure

Primary outcomes

  1. 12-month Viral Suppression

    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).

    Time frame: 12 months

Secondary outcomes

  1. Appointment Attendance

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

    Time frame: 12 months

  2. 6-month Viral Suppression

    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).

    Time frame: 6 month

  3. Proportion Virally Suppressed

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

    Time frame: 12 months

07

Study locations

1 site
  • Health for a Prosperous Nation (HPON)
    Dar es Salaam, Tanzania
08

References and documents

Publications

  • Sheira LA, Mlowe M, Katabaro E, Joseph B, Msasa J, Hassan K, Maila H, Winters S, Sabasaba A, Maokola W, Njau P, McCoy SI. Missed opportunities for PrEP among the partners of people newly initiated in HIV care in western Tanzania. J Acquir Immune Defic Syndr. 2026 Sep 30. doi: 10.1097/QAI.0000000000003968. Online ahead of print. PubMed 42814903 ↗
  • Winters S, Katabaro E, Joseph B, Msasa J, Maila H, Hassan K, Sabasaba A, Dow WH, Njau PF, McCoy SI. How do repeated financial incentives affect HIV care-seeking behaviours over time? Evidence from a cluster-randomised controlled trial. BMJ Glob Health. 2026 Feb 17;11(2):e022505. doi: 10.1136/bmjgh-2025-022505. PubMed 41702639 ↗
  • Katabaro E, Joseph B, Mwenda N, Bhattarai P, Msasa J, Mnyippembe A, Maila H, Hassan K, Kunesh J, Sabasaba A, Winters S, Njau P, Hemono R, McCoy SI, Packel L. Scaling-up an mHealth system to deliver financial incentives to improve adherence to antiretroviral therapy in Tanzania. Implement Sci Commun. 2025 Oct 3;6(1):100. doi: 10.1186/s43058-025-00766-1. PubMed 41044777 ↗
  • Njau PF, Katabaro E, Winters S, Sabasaba A, Hassan K, Joseph B, Maila H, Msasa J, Fahey CA, Packel L, Dow WH, Jewell NP, Ulenga N, Mwenda N, McCoy SI. Impact of financial incentives on viral suppression among adults initiating HIV treatment in Tanzania: a hybrid effectiveness-implementation trial. Lancet HIV. 2024 Sep;11(9):e586-e597. doi: 10.1016/S2352-3018(24)00149-8. Epub 2024 Aug 1. PubMed 39098325 ↗
  • Winters S, Sabasaba A, Fahey CA, Packel L, Katabaro E, Ndungile Y, Njau PF, McCoy SI. Increased prevalence of depression and anxiety among adults initiating antiretroviral therapy during the COVID-19 pandemic in Shinyanga region, Tanzania. AIDS Res Ther. 2023 Jun 10;20(1):36. doi: 10.1186/s12981-023-00534-y. PubMed 37301833 ↗
  • Packel L, Njau P, Fahey C, Ramadhani A, Dow WH, Jewell NP, McCoy S. Optimizing the efficiency and implementation of cash transfers to improve adherence to antiretroviral therapy: study protocol for a cluster randomized controlled trial. Trials. 2020 Nov 23;21(1):963. doi: 10.1186/s13063-020-04899-7. PubMed 33228757 ↗

Individual participant data

Plan to share: No

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 Mar 2020 to primary completion in Nov 2023, 44 months.

Of 497 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 47. This study's 44 months is above that.

Counting every sponsor, half of 500 studies reached it within 31 months; a quarter within 18 and three quarters within 47.

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

Registered
Dec 11, 2019
First posted
Dec 17, 2019
StartActual
Mar 9, 2020
Primary completionActual
Nov 10, 2023
CompletionActual
Jun 30, 2024
Last update
Aug 19, 2024
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 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04201353
Collaborators
Health for a Prosperous Nation, Rasello, Tanzania Ministry of Health, Community Development, Gender, Elderly and Children
Responsible party
Sandra McCoy (Associate Professor in Residence, University of California, Berkeley) — Principal investigator
First posted
Dec 17, 2019
Start date
Mar 9, 2020
Primary completion
Nov 10, 2023
Completion
Jun 30, 2024
Last update
Aug 19, 2024

Study contacts

Sandra McCoy, PhD
principal investigator · University of California, Berkeley

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 2024. You cannot join it, but the record below documents what was studied.

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