HIV (Human Immunodeficiency Virus)RKPK: Phase INCT05248100
Rudi Kundini, Pamoja Kundini: Phase I
A study testing Conditional Cash Transfer in people with HIV (Human Immunodeficiency Virus), run by University of California, Berkeley at 2 sites in Tanzania.
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 6 months among people living with HIV infection (PLHIV) in Tanzania who have disengaged from HIV care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV (Human Immunodeficiency Virus)
- What is being tested?
- Conditional Cash Transfer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 567 participants
- Where
- 2 sitesTanzania
- Study dates
- 13 Jul 2022to 3 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PLHIV living in the catchment area of a study health facility;
- Age 18 years or older;
- Phone ownership OR phone consistent phone access;
- Classified as lost to follow up (LTFU) from HIV care (not attended a clinic appointment for ≥28 days since last scheduled appointment);
- Has had a clinic appointment within the last 24 months, and
- Provides written informed consent for participation
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Strengthening the Continuity of HIV Care in Tanzania With Economic Support: Phase I
This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 6 months among people living with HIV infection (PLHIV) in Tanzania who have disengaged from HIV care. Randomization will take place at the clinic level (HIV primary care clinics). The comparison group receives standard of care standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible adult PLHIV disengaged from HIV care and living in an intervention facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time cash transfer incentive, conditional upon confirmed completion of a clinical visit if within 90 days of study enrollment. The primary endpoint is viral suppression (<1000 copies/ml) at 6 months after study enrollment.
Read the detailed description
The overall objective of this study is to evaluate the effectiveness of a home visit plus one-time financial incentive on the proportion of out of care PLHIV with viral load suppression (<1000 copies/ml) at 6 months after study enrollment. We will use a cluster, randomized controlled trial design with a sample size of 20 PLHIV in each of the 32 health facility catchment areas (N=640 PLHIV total) to examine the effect of a home visit plus one-time financial incentive on the primary outcome of viral suppression at 6 months. The study will take place across Geita and Kagera Regions (Lake Zone) in Tanzania.
This study will follow standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible and consenting participants living in an intervention health facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time incentive of 22,500 TSH (~$10 USD), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment.
Primary Endpoint:
- Viral suppression (<1000 copies/ml) at 6 months after enrollment
Secondary Endpoints:
- Viral suppression at 12 months after enrollment
- Durable viral suppression at 12 months after enrollment
- Appointment attendance
- Time to re-linkage to care
- Mortality at 12 months after enrollment
- Re-linkage to care at 12 months after enrollment
- Retention at 6 and 12 months, defined as the proportion of PLHIV on antiretroviral therapy (ART) at 6 months after enrollment and 12 months after enrollment, respectively
- Conditions
- HIV (Human Immunodeficiency Virus)
- Being tested
- Conditional Cash Transfer
- Keywords
- Conditional Cash Transfers, Tanzania, People Living With HIV
- 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 one-time cash transfer of 22,500 Tanzanian Shillings (~$10), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Conditional Cash Transfer | Experimental | Eligible and consenting participants living in an intervention health facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time incentive of 22,500 Tanzanian Shillings (TSH) (~$10), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment. Receives: Behavioral: Conditional Cash Transfer |
| Control | No intervention | Eligible and consenting participants living in a control health facility catchment area will receive the standard of care HIV tracing and clinical services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 6-month Viral Suppression
The proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 6 months following study enrollment. 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 months
Secondary outcomes (10)
Number of Participants With 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 following study enrollment. 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, the World Health Organization (WHO) threshold for virologic failure in low- and middle-income countries (LMIC)) versus not on ART or viral failure (≥1000 copies/ml).
Measured: 12 months
Number of Participants With 12-month Durable Viral Suppression
The proportion of people living with HIV (PLHIV) with durable HIV viral suppression at 12 months after study enrollment months (either: 1) ≥2 assessments of viral load, taken from up to 6 months prior to study enrollment and up to and including 12 months following study enrollment (the recommended timing of immunologic monitoring for stable PLHIV on ART with viral suppression), or 2) ≥3 assessments if baseline viral load is >1000 copies/ml (the recommended timing of immunologic monitoring mandates an additional follow-up assessment 3 months and again at 12 months)
Measured: 12 months
Total Number of Attended Visits Across All Scheduled Visits Between 0 to 6 Months
Number of scheduled visits that were completed during the 0-6 month period
Measured: 6 months
Total Number of Attended Visits Across All Scheduled Visits Between 0 to 12 Months
Number of scheduled visits attended between 0 and 12 months
Measured: 12 months
Incidence of Mortality at 12-month
The cumulative incidence of all-cause mortality at 12 months after study enrollment
Measured: 12 months
Proportion of Participants Virally Suppressed Within 12-months
Proportion of PLHIV with viral suppression in the 0-12-month follow-up period
Measured: 12 months
Number of Participants at 12-months Re-linked to HIV Care
Number of participants re-linked to to HIV care over 0 to 12 months, after study enrollment
Measured: 12 months
Time to Re-linkage to HIV Care
Time for patients to re-link back to HIV care
Measured: 12 months
Number of Participants at 6-months Retained in Care
The number of people living with HIV (PLHIV) on ART at 6 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)
Measured: 6 months
Number of Participants at 12-months Retained in Care
The proportion of people living with HIV (PLHIV) on ART at 12 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start13 Jul 2022
- Primary completion12 Jul 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Health for a Prosperous Nation, Rasello, Ministry of Health, Tanzania, National Institute of Mental Health (NIMH), Management and Development for Health (MDH), Tanzania
- Responsible party
- Sponsor
- Investigators
- Jingshen Wang, PhD, Principal investigator, University of California, BerkeleyAmon Sabasaba, MD, Principal investigator, Health for a Prosperous Nation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248100
- Sponsor's protocol ID
- R01MH125746
- Other IDs
- R01MH125746
- Acronym
- RKPK: Phase I
- Status last verified
- Sep 2025
- First submitted
- 9 Feb 2022
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Provided upon request
Publications
Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania. Trials. 2024 Feb 10;25(1):114. doi: 10.1186/s13063-024-07960-x.
PubMed 38336793Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania. Res Sq [Preprint]. 2023 Dec 20:rs.3.rs-3315136. doi: 10.21203/rs.3.rs-3315136/v1.
PubMed 38196655
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening the Continuity of HIV Care in Tanzania With Economic Support: Phase I
- ClinicalTrials.gov ID
- NCT05248100
- Acronym / sponsor ID
- RKPK: Phase I / R01MH125746
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- Conditional Cash Transfers, Tanzania, People Living With HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Health for a Prosperous Nation, Rasello, Ministry of Health, Tanzania, National Institute of Mental Health (NIMH), Management and Development for Health (MDH), Tanzania
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Posted 22 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 6 months among people living with HIV infection (PLHIV) in Tanzania who have disengaged from HIV care. Randomization will take place at the clinic level (HIV primary care clinics). The comparison group receives standard of care standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible adult PLHIV disengaged from HIV care and living in an intervention facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time cash transfer incentive, conditional upon confirmed completion of a clinical visit if within 90 days of study enrollment. The primary endpoint is viral suppression (<1000 copies/ml) at 6 months after study enrollment.
Detailed description
The overall objective of this study is to evaluate the effectiveness of a home visit plus one-time financial incentive on the proportion of out of care PLHIV with viral load suppression (<1000 copies/ml) at 6 months after study enrollment. We will use a cluster, randomized controlled trial design with a sample size of 20 PLHIV in each of the 32 health facility catchment areas (N=640 PLHIV total) to examine the effect of a home visit plus one-time financial incentive on the primary outcome of viral suppression at 6 months. The study will take place across Geita and Kagera Regions (Lake Zone) in Tanzania.
This study will follow standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible and consenting participants living in an intervention health facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time incentive of 22,500 TSH (~$10 USD), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment.
Primary Endpoint:
- Viral suppression (<1000 copies/ml) at 6 months after enrollment
Secondary Endpoints:
- Viral suppression at 12 months after enrollment
- Durable viral suppression at 12 months after enrollment
- Appointment attendance
- Time to re-linkage to care
- Mortality at 12 months after enrollment
- Re-linkage to care at 12 months after enrollment
- Retention at 6 and 12 months, defined as the proportion of PLHIV on antiretroviral therapy (ART) at 6 months after enrollment and 12 months after enrollment, respectively
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conditional Cash Transfer | Experimental | Behavioral: Conditional Cash TransferEligible and consenting participants living in an intervention health facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time incentive of 22,500 Tanzanian Shillings (TSH) (~$10), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment. |
| Control | No intervention | –Eligible and consenting participants living in a control health facility catchment area will receive the standard of care HIV tracing and clinical services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PLHIV living in the catchment area of a study health facility;
- Age 18 years or older;
- Phone ownership OR phone consistent phone access;
- Classified as lost to follow up (LTFU) from HIV care (not attended a clinic appointment for ≥28 days since last scheduled appointment);
- Has had a clinic appointment within the last 24 months, and
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditional Cash TransferThe intervention is a one-time cash transfer of 22,500 Tanzanian Shillings (~$10), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment. | Behavioural | Conditional Cash Transfer |
Primary outcome
Number of Participants With 6-month Viral Suppression
Time frame: 6 months
The proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 6 months following study enrollment. 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).
10 secondary outcomes
Number of Participants With 12-month Viral Suppression
Time frame: 12 months
Number of Participants With 12-month Durable Viral Suppression
Time frame: 12 months
Total Number of Attended Visits Across All Scheduled Visits Between 0 to 6 Months
Time frame: 6 months
Total Number of Attended Visits Across All Scheduled Visits Between 0 to 12 Months
Time frame: 12 months
Incidence of Mortality at 12-month
Time frame: 12 months
Proportion of Participants Virally Suppressed Within 12-months
Time frame: 12 months
Number of Participants at 12-months Re-linked to HIV Care
Time frame: 12 months
Time to Re-linkage to HIV Care
Time frame: 12 months
Number of Participants at 6-months Retained in Care
Time frame: 6 months
Number of Participants at 12-months Retained in Care
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38336793Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania. Trials. 2024 Feb 10;25(1):114. doi: 10.1186/s13063-024-07960-x.
- Derived from this study: PubMed 38196655Kadota JL, Packel LJ, Mlowe M, Ulenga N, Mwenda N, Njau PF, Dow WH, Wang J, Sabasaba A, McCoy SI. Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania. Res Sq [Preprint]. 2023 Dec 20:rs.3.rs-3315136. doi: 10.21203/rs.3.rs-3315136/v1.
- Individual participant dataSharing planned: Yes. Provided upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingshen Wang, PhD principal investigator
University of California, Berkeley
Amon Sabasaba, MD principal investigator
Health for a Prosperous Nation
2 sites in 1 country: see every site and its status.
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 2 sites 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 6 inclusion and 0 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 22 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With 6-month Viral Suppression (time frame: 6 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 NCT05248100, which also lists 2 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 22 Sep 2026.