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HIV (Human Immunodeficiency Virus)Afya 2 Phase2NCT04201353

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

A study testing Conditional Cash Transfer in people with HIV (Human Immunodeficiency Virus), run by University of California, Berkeley at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV (Human Immunodeficiency Virus)
What is being tested?
Conditional Cash Transfer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,984 participants
Where
1 siteTanzania
Study dates
9 Mar 2020to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • Health for a Prosperous Nation (HPON)

    Dar es Salaam

Other trials in Tanzania

About this study

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

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.

Being tested
Conditional Cash Transfer
Keywords
Antiretroviral Treatment Adherence, Conditional Cash Transfers, Tanzania, People Living With HIV, Behavioral Economics
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conditional Cash TransferBehavioural

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

Study groups in NCT04201353
Study groupRoleWhat they receive
Conditional Cash TransferExperimentalParticipants 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.
Receives: Behavioral: Conditional Cash Transfer
ControlNo interventionParticipants attending control clinics will receive the standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 months

Secondary outcomes (3)

  1. Appointment Attendance

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

    Measured: 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).

    Measured: 6 month

  3. Proportion Virally Suppressed

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2019
  2. Study start9 Mar 2020
  3. Primary completion10 Nov 2023
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
2-arm cluster randomized control trial, with HIV primary care clinic as the unit of randomization
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,984 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04201353
Sponsor's protocol ID
R01MH112432-01A2
Acronym
Afya 2 Phase2
Status last verified
Aug 2024
First submitted
11 Dec 2019
Last updated
19 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Conditional Cash Transfer in people with HIV (Human Immunodeficiency Virus), run by University of California, Berkeley at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month Viral Suppression (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04201353, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.

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