Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy - The RELAI Study

Browse trials for

• HIV Infections 4,340

Keywords

• LA-CAB/RPV
• HIV care

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 40 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,367 studies on the registry; 134 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 139 (88%) have results posted.

Study arms

• Experimental
  Field-based LA-CAB/RPV

  Drug: Field-based LA-CAB/RPV

Interventions

• DrugField-based LA-CAB/RPV

  Participants will receive their first does of long-acting cabotegravir 600 mg and rilpivirine 900 mg by separate intramuscular gluteal injections on Day 0 in a secure, community-based location of their choosing (such as their home). Additional field-based injections will be available at Week 4, and then every 2 months at Weeks 12, 20, and 28, though participants can instead choose to receive injections in the clinic instead.

Primary outcomes

1. Percent of preliminarily eligible participants who accept and receive field-based injection (acceptability)

   Time frame: From enrollment to the end of participation at 7 months

2. Median acceptability of intervention (AIM) score (acceptability)

   AIM scores are calculated using the following scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scores are calculated from a version of the following four questions: (1) The intervention meets my approval, (2) The intervention is appealing to me, (3) I like the intervention, and (4) I welcome the intervention. Scores are summed across participant and summaries of these scores are provided, minimum score is 4 and maximum score is 20 which corresponds to perfect acceptability.

   Time frame: Month 3, Month 7

3. Median HIV treatment burden score (acceptability)

   The Treatment burden Questionnaire (TBQ) is a self-reported questionnaire assessing the burden of treatment without restricting its scope to a single condition or treatment context. It has been adapted to include 13 items rated on a Likert scale ranging from 0 (not at all difficult) to 5 (extremely difficult) related to the burden associated with taking medicine, self-monitoring, laboratory tests, physician visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of the treatment. Item scores can be summed into a global score, ranging from 13 to 65. Higher scores reflect higher treatment burden.

   Time frame: Month 0, Month 3, Month 7

4. Percentage of participants who receive all indicated LA-CAB/RPV injections within the allowable 14-day window (feasibility)

   As extracted from study administration and, where appropriate, clinic records, the date of injections will be determined as falling within or outside the acceptable window period. This outcome will be calculated as the percent of all participants with an indication for receipt of LA-CAB/RPV (that is, has not been excluded from further injections identified after receipt of first injection or failure to achieve appropriate decline in HIV RNA levels or viral suppression prompting transition to alternative agent), who receive all indicated injections within the acceptable 14-day window period, as determined by the date of the prior injection.

   Time frame: From enrollment to the end of participation at 7 months

Secondary outcomes

1. Percentage of participants with HIV RNA <200 copies/mL at 7 months (viral suppression)

   Among all participants with HIV RNA available within allowable final study visit window (week 28) (obtained through study procedures or clinical care), percent with HIV RNA \<200 copies/mL. Participants without HIV RNA available within allowable final study visit window (week 28), and for whom \>2 months have elapsed since their last injection at the end of closure of that window will be assumed to have HIV RNA \>200 copies/mL.

   Time frame: Month 7

2. Percentage of participants with HIV RNA <200 copies/mL at their end of study visit (viral suppression)

   among all participants based on their final study visit, regardless of retention in study procedures through 7-month follow-up, percent with HIV RNA \<200 at their final study visit.

   Time frame: From enrollment through end of study (month 7)

3. Percentage of participants with viremia >200 copies/mL at enrollment who suppress to <200 copies/mL by month 7 (viral suppression)

   Among participants who have an HIV RNA \>200 copies/mL on D0, the percent who have at least one HIV RNA \<200 copies/mL during follow-up evaluations through month 7.

   Time frame: From enrollment through end of study (month 7)

4. Percentage of participants with a HIV clinic visit within 7 months from enrollment on study (re-engagement)

   Among all enrolled persons, what percent attended at least one clinic visit (in-person or virtual) with a non-study affiliated primary HIV provider within 7-month follow-up period.

   Time frame: From enrollment through end of study (month 7)

5. Percentage of eligible PWH contacted (recruitment and engagement)

   Among persons with HIV who are pre-screened as eligible and with at least one contact attempt made by study staff, what percent are contacted (defined as speaking to person directly, receiving response back via text or preferred messaging medium, or encountering in-person), regardless of persons eventual eligibility or screening outcomes.

   Time frame: from screening to end of recruitment (~12 months)

6. Percentage of contacted PWH who are screened for the study (recruitment and engagement)

   Among persons with HIV who are contacted (defined as having at least one contact made by staff including speaking to person directly, receiving response back via text or preferred messaging medium, or encountering in-person), what percent undergo screening for study eligibility

   Time frame: from screening to end of recruitment (~12 months)

Individual participant data

Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Supporting information: Study protocol, Informed consent form

Time frame: beginning 9 and continuing for 36 months following publication

Access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC