Innovate, Involve, Inspire

Sponsor
Frontline AIDS
Study ID
NCT06604182
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Community-based Simplified HCV Testing and Treatment Algorithm — OTHER
    The distinctive features of CBSA are: (i) community-based service provision, substantially lowering the threshold for HCV services and eliminating the need to visit health care facilities for the majority of patients; (ii) the use of simple, once-daily, pan-genotypic HCV treatment regimens; (iii) a minimum of required laboratory tests and assessments; (iv) task sharing of essential functions from physicians to the case-managers; (v) integration of HCV testing and treatment with existing harm reduction services, addressing multiple health needs and facilitating patient-centered care.

Study Details

The study will test a Community-based Simplified HCV Testing and Treatment Algorithm (CBSA), implemented at community harm reduction fixed or mobile sites. All potential participants with positive anti-HCV test will undergo diagnostic procedures including HCV-RNA testing. Those eligible for CBSA will be prescribed a fixed dose combination tablet: sofosbuvir/daclatasvir. Sustained virologic response (SVR) will be assessed 12 weeks after treatment completion. All those who achieve SVR will be tested for HCV\_RNA at six and 12 months after SVR12.

Key Dates

Start date
Jan 31, 2025
Status verified
Sep 2024
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
1,454 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HCV positive
    Eligible participants that are HCV infected.

Primary Outcome Measure

Number of participants successfully completing HCV treatment [ Time Frame: 15 months ]

Central Contacts

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