Combined injectable treatment for HIV and opioid use disorder
Integrating Long-Acting Injectable Treatment to Improve Medication Adherence Among Persons Living With HIV and Opioid Use Disorder
This study is trying to see how people feel about using a new combined injectable treatment for those living with both HIV and opioid use disorder.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rhode Island Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05991622 on ClinicalTrials.gov |
What this trial studies
This one-year study evaluates the perspectives on combined injectable treatment for HIV and opioid use disorder (OUD) using long-acting medications like cabotegravir with rilpivirine and extended-release buprenorphine. The study will conduct qualitative interviews with 32-45 key stakeholders to assess their interest, knowledge, attitudes, barriers, and facilitators regarding integrated injectable treatment. The findings aim to inform clinical strategies that promote the uptake and maintenance of these long-acting injectable medications, ultimately improving care coordination and clinical outcomes for patients with both conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with documented HIV-1 infection and a current diagnosis of opioid use disorder.
Not a fit: Patients who are currently pregnant, breastfeeding, or planning to become pregnant during the study period may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved adherence and better health outcomes for patients with HIV and OUD through integrated treatment.
How similar studies have performed: While integrated treatment approaches have shown promise in other studies, this specific combination of long-acting injectable treatments is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-65 years of age * HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay * Current diagnosis of OUD according to DSM-5 * Able to understand and speak English and to provide written and verbal informed consent * Participants recruited through RIDOC will have an additional requirement of anticipated release from jail/prison within 6 months. Exclusion Criteria: * Currently pregnant, breastfeeding, planning to become pregnant or breastfeed during the study period * Coinfection of Hepatitis B or plans to get treated for Hepatitis C during the study period
Where this trial is running
Providence, Rhode Island
- Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Kirsten K Langdon, Ph.D. — Rhode Island Hospital
- Study coordinator: Kirsten K Langdon, Ph.D.
- Email: kirsten.langdon@lifespan.org
- Phone: 401-606-4198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.