- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05248100
Rudi Kundini, Pamoja Kundini: Fas I (RKPK: Phase I)
Att stärka kontinuiteten i HIV-vården i Tanzania med ekonomiskt stöd: Fas 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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:
1. 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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Geita, Tanzania
- Geita Region
-
Kagera, Tanzania
- Kagera Region
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Conditional Cash Transfer
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. |
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. |
|
Inget ingripande: Control
Eligible and consenting participants living in a control health facility catchment area will receive the standard of care HIV tracing and clinical services. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With 6-month Viral Suppression
Tidsram: 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). |
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With 12-month Viral Suppression
Tidsram: 12 months
|
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). |
12 months
|
|
Number of Participants With 12-month Durable Viral Suppression
Tidsram: 12 months
|
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) |
12 months
|
|
Total Number of Attended Visits Across All Scheduled Visits Between 0 to 6 Months
Tidsram: 6 months
|
Number of scheduled visits that were completed during the 0-6 month period |
6 months
|
|
Total Number of Attended Visits Across All Scheduled Visits Between 0 to 12 Months
Tidsram: 12 months
|
Number of scheduled visits attended between 0 and 12 months |
12 months
|
|
Incidence of Mortality at 12-month
Tidsram: 12 months
|
The cumulative incidence of all-cause mortality at 12 months after study enrollment |
12 months
|
|
Proportion of Participants Virally Suppressed Within 12-months
Tidsram: 12 months
|
Proportion of PLHIV with viral suppression in the 0-12-month follow-up period |
12 months
|
|
Number of Participants at 12-months Re-linked to HIV Care
Tidsram: 12 months
|
Number of participants re-linked to to HIV care over 0 to 12 months, after study enrollment |
12 months
|
|
Time to Re-linkage to HIV Care
Tidsram: 12 months
|
Time for patients to re-link back to HIV care |
12 months
|
|
Number of Participants at 6-months Retained in Care
Tidsram: 6 months
|
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) |
6 months
|
|
Number of Participants at 12-months Retained in Care
Tidsram: 12 months
|
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) |
12 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Jingshen Wang, PhD, University of California, Berkeley
- Huvudutredare: Amon Sabasaba, MD, Health for a Prosperous Nation
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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. Res Sq [Preprint]. 2023 Dec 20:rs.3.rs-3315136. doi: 10.21203/rs.3.rs-3315136/v1.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Blodburna infektioner
- Urogenitala sjukdomar
- Genitala sjukdomar
- Immunsystemets sjukdomar
- Infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Smittsamma sjukdomar
- Sexuellt överförbara sjukdomar, virala
- Sexuellt överförbara sjukdomar
- Lentivirusinfektioner
- Retroviridae-infektioner
- Immunologiska bristsyndrom
- Långsamma virussjukdomar
- HIV-infektioner
- Förvärvat immunbristsyndrom
Andra studie-ID-nummer
- R01MH125746 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Provided upon request
Kriterier för IPD Sharing Access
Provided upon request
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
Läkemedels- och apparatinformation, studiedokument
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