Active — Not RecruitingPhase 2

Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs

United States50 participantsStarted 2024-08-01

Plain-language summary

This study addresses real-world use of long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model (CDTM+) that will be expanded for telehealth outreach to women with health-related social needs (HRSN).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Living with diagnosed HIV * Receiving HIV care-related services from Yale New Haven Health (YNHH) * Currently on oral ART and virally suppressed for at least 6 months (from electronic health review). * Have experienced at least one HRSN: a) homelessness or housing insecurity; b) food insecurity; c) criminal legal system involvement; OR d) substance use in the past 3 years (from self-report at screening). * Able to converse comfortably in English or Spanish Exclusion Criteria: * Unable or unwilling to complete informed consent (e.g., have a conservator of person) * Have initiated CAB/RPV oral lead-in prior to enrollment. * Have a contraindication to CAB/RPV LA per label. * Have known or suspected resistance to CAB/RPV * Pregnant or breast-feeding

What they're measuring

Feasibility of CDTM+

Timeframe: Baseline, Month 12

Acceptability of CDTM+

Timeframe: Baseline, Month 12

Evaluate the adoption of CAB/RPV LA in the population receiving CDTM+

Timeframe: Month 12

Trial details

NCT IDNCT06411223

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

View on ClinicalTrials.gov More Hiv trials