El Centro Hispano
Durham, North Carolina, 27701, United States
Location status: Recruiting
Location contact
Alma Ortega
SUB_INVESTIGATOR
Emilia Ismael-Simental
SUB_INVESTIGATOR
Orlando Martinez J Peer Navigator
CONTACT
NCT Number: NCT07218211
The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.
Interested in participating?
Request Info18 year and older
Male
Interventional
Phase 4
Durham, North Carolina, 27701, United States
Location status: Recruiting
Alma Ortega
SUB_INVESTIGATOR
Emilia Ismael-Simental
SUB_INVESTIGATOR
Orlando Martinez J Peer Navigator
CONTACT
We propose a mixed methods hybrid type 3 implementation study, which primarily tests an implementation strategy while collecting data on the clinical intervention and related outcomes. Building on existing partnerships between Duke University and El Centro Hispano, we will integrate lenacapavir delivery on-site at El Centro Hispano facilities, leveraging El Centro Hispano Peer Navigators to provide culturally congruent support for PrEP uptake, adherence, and persistence among Latine GBM and TGW.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir)
Other names: Yeztugo, Lenacapavir injection, PrEP, Injectable PrEP
Time frame: up to 1 year
Qualitative identification: "What gets in the way of people in your community starting PrEP? Staying on PrEP?"
Time frame: up to 1 year
Qualitative identification: "Recommendations to address these barriers?"
Time frame: up to 1 year
Qualitative identification: "What factors support people in your community?"
Time frame: up to 1 year
AARP items will help quantify acceptability and will help validate community perceptions: "I believe lenacapavir injections are an effective way to prevent HIV", "I would be willing to receive lenacapavir injections in the future when this study is complete", "Receiving lenacapavir in a community setting fits my lifestyle and preferences", "I feel comfortable receiving lenacapavir injections from professionals working with El Centro", "I would recommend lenacapavir to a friend who is at risk for HIV", "I found lenacapavir preferable to oral PrEP", "Compared to a daily pill, I feel that injectable PrEP gives me more privacy", "I am concerned about possible side effects from lenacapavir injections", "Compared to a daily pill, I feel that injectable PrEP reduces concerns about being judged by others"
Time frame: up to 1 year
The PSAT will provide a structured way to assess organizational capacity and sustainability for scale up. It has a score range of 0 to 40, where a higher score indicates greater feasibility.
Contact information is provided by the study sponsor or research team.
Duke University
Other
INCLUSION - Enhancing PrEP Uptake and Retention Among Latine Transgender Women and Gay, Bisexual, and Other Men Who Have Sex With Men in the South Using Long-Acting Injectable PrEP
Acronym: INCLUSION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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