Innovate, Involve, Inspire

ConditionHCV

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorFrontline AIDS

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Drug use in the past 90 days

Age 18 and above

Positive for HCV RNA

Disqualifiers

No meeting inclusion criteria

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

Community-based Simplified HCV Testing and Treatment Algorithm
Other intervention
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.

Treatment groups

1,454 Participants

are divided into 1 treatment group

Group A: HCV positiveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of participants successfully completing HCV treatment

Hepatitis C screening, confirmation and treatment will be monitored for the number of confirmed positive participants that enroll and complete treatment. Suppression of the virus will be recorded per participant as well as re-infection rates up to 1 year after treatment was completed.

Time frame

15 months

Secondary outcomes

The percentage of participants with treatment satisfaction using a tool called: Health seeking behavior and health service utilization

The tool will measure, in the last 6 months, the number of times participants 1. seeked medical assistance, 2. if assistance was provided, 3. the reason for not seeking assistance (if relevant) and 4. treatment satisfaction (if assistance was provided). These multiple measurements will be aggregated to give a score per participant used to classify participants into percentage with and without treatment satisfaction.

Time frame

15 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Frontline AIDS

Lead sponsor

Alliance for the Public's Health

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: