PWID Opportunities to Improve Treat and Retain (POINTER)
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
Unspecified
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
Clinical Trials Website Interest FormBrief Summary
The goal of this study is to improve HIV care outcomes for people who inject drugs (PWID) in India. The study will implement a two-phase trial to evaluate whether HIV treatment outcomes (HIV viral suppression) in HIV infected PWID can be improved with three different interventions: i) by offering a faster treatment start time (same-day antiretroviral therapy [ART] initiation vs. standard), ii) by provided community-based HIV care in PWID-focused centers (vs. centralized government-based HIV care) and, iii) providing an enhanced adherence support to participants who experience treatment failure at six months (vs. routine adherence support). The investigators hypothesize that faster access to ART and HIV treatment in PWID-focused community sites will lead to higher levels of initiation and retention to ART compared with standard care; and use of enhanced navigation and psychosocial support to patients who experience treatment failure at six months will lead to improved viral suppression compared with routine adherence support.
Eligibility
PHASE 1 Inclusion Criteria:
- 18 years of age or older
- Reports injection drug use in prior 24 months
- Documented HIV positive
- Antiretroviral therapy naïve
- HIV RNA 1,000 c/mL or higher
- If previously linked to HIV care, able and willing to provide govt. ART book for documentation of care received.
PHASE 1 Exclusion Criteria:
- Pregnant (if female)
- Does not speak English, Hindi, or local language
- Plans to migrate in next 12 months
- Not competent to participate in the study or provide written informed consent.
PHASE 2 Inclusion Criteria:
• Participants who experience treatment failure at 6 months (HIV RNA>1000c/mL)
PHASE 2 Exclusion Criteria:
• Participants who do not experience treatment failure at 6 months