Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color

NCT04018651 | Completed

• 1 other identifier: FIU IRB 105978
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Nationally, the HIV case rate among black/ African American (AA) women is nearly 20 times higher than in white women; for Hispanic/Latino women it is 4.5 times higher. Moreover, according to findings in the HIV Prevention Trials Network (HPTN) Study 064 (The Women's HIV SeroIncidence Study), HIV incidence among women who live in communities with high HIV prevalence and poverty is about 6 times higher than for black/AA women. South Florida's new HIV diagnoses are now triple the national average due to rates in Miami-Dade and Broward counties in its AA, Latino and Haitian communities. Black women follow black men who have sex with men (MSM) as the most crisis-ridden of the communities in South Florida, the state as a whole, the South, and the U.S. Women overall have been at a disadvantage in the HIV epidemic due to gender differences and norms that shape biological, social and economic vulnerability. Racial and ethnic disparities magnify the risk. Co-factors such as alcohol and other drug (AOD) use intersect and reinforce other comorbidities. Living in a high prevalence area significantly hardens the risk and makes it tougher to overcome. Options to help women stay HIV negative have been limited, and the absence of practical female-controlled prevention strategies and relative dependence on cooperative use of the male condom continue to keep women's HIV vulnerability high. This obstacle shifted several years ago with FDA approval and Centers for Disease Control and Prevention's (CDC) endorsement of oral pre-exposure prophylaxis (PrEP). However, women do not know about PrEP. Despite FDA approval in 2012, followed by expansions in recommended use from the CDC and World Health Organization (WHO), the majority of women in the U.S. are not aware of oral PrEP as an HIV prevention strategy that applies to them. This study utilizes community-based participatory research (CBPR) to develop an intervention program that will promote optimal PrEP utilization among women of color in South Florida. The overall goal is to determine how best to target and improve PrEP utilization among women of color with substantial risks for HIV, including alcohol use.

Conditions

HIV Prevention

Keywords

Pre-Exposure Prophylaxis; PrEP

Outcome Measures

Primary Outcomes (4)

• Number of Participants receiving 3 Medication Appointments

  Number of Participants who receive 3 refills of medication for PrEP

  3 months

• Percentage Adherence to PrEP Medication

  Percentage adherence based on Pill count of remaining prescription medication at 3 months

  3 months

• Self reported PrEP Adherence

  Percentage Adherence to daily PrEP medication via self report at 3 months

  3 months

• Number of Participants reporting Adherence to HIV testing recommendation

  Number of Participants Receiving HIV test at 3 months

  3 months

Study Arms (1)

PrEP Master Adherence Intervention

EXPERIMENTAL

The intervention consists of an introductory session and 4 individual sessions led by the PrEP Master, over an 8 week period. Between the sessions, the PrEP Master will conduct weekly check-in calls to participants to encourage adherence and assist with difficulties. During the weekly check-in, side effects and their impact will be assessed using assessment measures.

Behavioral: PrEP Master Adherence Intervention

Interventions

PrEP Master Adherence Intervention BEHAVIORAL

The PrEP Master Adherence Intervention consists of 4 face to face individual education sessions and a series of telephone contacts to identify barriers and facilitators to optimal PrEP adherence over a six-month period. Each PrEP Master education session includes a review of an individualized plan to reduce risk, review of information about PrEP, and different discussion points. Key messages include: 1. Importance of daily adherence; 2. Three week delay for full effectiveness describing PrEP like taking the birth control pill; 3. Condom use for other sexually transmitted infection (STI) prevention; 4. Pregnancy prevention plans; 5. Plans for follow up calls 6. Referral to other treatment services if necessary

PrEP Master Adherence Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• + years of age;
• born female;
• Identifies as female;
• Identifies as African American, Hispanic/Latina or Haitian (self or parent);
• Able to provide informed consent;
• HIV uninfected;
• Sexual risk (previous STI, inconsistent condom use, transactional sex, HIV infected partner);
• History of alcohol or drug use in last 3 months;
• No uncleared PrEP contraindications;
• No psychosis.

You may not qualify if:

• Less than 18 years of age
• male gender assignment at birth
• current male gender identity
• does not identify as African American, Haitian or Hispanic/Latina (self or parent)
• reports history of or current untreated psychosis
• unable to provide informed consent
• HIV infected
• Refuses PrEP medication
• Untreated medical contraindication for PrEP

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University Biscayne Bay Campus

North Miami, Florida, 33181, United States

Location

Study Officials

• Jessy G Dévieux, Ph.D.

  Florida International Univ.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: July 12, 2019
• Study Start: May 31, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)