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Rudi Kundini, Pamoja Kundini: Fas I (RKPK: Phase I)

26 augusti 2026 uppdaterad av: University of California, Berkeley

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

Avslutad

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:

  1. Viral suppression at 12 months after enrollment
  2. Durable viral suppression at 12 months after enrollment
  3. Appointment attendance
  4. Time to re-linkage to care
  5. Mortality at 12 months after enrollment
  6. Re-linkage to care at 12 months after enrollment
  7. 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

Interventionell

Inskrivning (Faktisk)

567

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Geita, Tanzania
        • Geita Region
      • Kagera, Tanzania
        • Kagera Region

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. PLHIV living in the catchment area of a study health facility;
  2. Age 18 years or older;
  3. Phone ownership OR phone consistent phone access;
  4. Classified as lost to follow up (LTFU) from HIV care (not attended a clinic appointment for ≥28 days since last scheduled appointment);
  5. Has had a clinic appointment within the last 24 months, and
  6. Provides written informed consent for participation

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

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

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Jingshen Wang, PhD, University of California, Berkeley
  • Huvudutredare: Amon Sabasaba, MD, Health for a Prosperous Nation

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

13 juli 2022

Primärt slutförande (Faktisk)

12 juli 2024

Avslutad studie (Faktisk)

3 december 2024

Studieregistreringsdatum

Först inskickad

9 februari 2022

Först inskickad som uppfyllde QC-kriterierna

9 februari 2022

Första postat (Faktisk)

21 februari 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 augusti 2026

Senast verifierad

1 september 2025

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

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

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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