- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05248100
Rudi Kundini, Pamoja Kundini: Fase I (RKPK: Phase I)
Rafforzare la continuità della cura dell'HIV in Tanzania con il sostegno economico: fase 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Geita, Tanzania
- Geita Region
-
Kagera, Tanzania
- Kagera Region
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Nessun intervento: Control
Eligible and consenting participants living in a control health facility catchment area will receive the standard of care HIV tracing and clinical services. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With 6-month Viral Suppression
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With 12-month Viral Suppression
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 months
|
Number of scheduled visits attended between 0 and 12 months |
12 months
|
|
Incidence of Mortality at 12-month
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 months
|
Time for patients to re-link back to HIV care |
12 months
|
|
Number of Participants at 6-months Retained in Care
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Jingshen Wang, PhD, University of California, Berkeley
- Investigatore principale: Amon Sabasaba, MD, Health for a Prosperous Nation
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Infezioni a trasmissione ematica
- Malattie urogenitali
- Malattie genitali
- Malattie del sistema immunitario
- Infezioni
- Infezioni da virus a RNA
- Malattie virali
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie da virus lenti
- Infezioni da HIV
- Sindrome da immunodeficienza acquisita
Altri numeri di identificazione dello studio
- R01MH125746 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Provided upon request
Criteri di accesso alla condivisione IPD
Provided upon request
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .