PrEP Adherence Monitoring
Conditions
Keywords
HIV, Truvada
Brief summary
The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.
Detailed description
Study Design: This is a 24 week prospective pilot study assessing attitudes toward and feasibility of using Truvada PrEP in a population of women at risk for HIV acquisition.At this site 31 HIV- uninfected women desiring PrEP will be enrolled at each site (confirm number). We will have to consent about 50 women which includes screen failures.The study will assess attitudes towards and adherence to PrEP with questionnaires at weeks 12 and 24. Tenofovir levels procured at week 12 and 24 week of PrEP will be used to assess adherence to PrEP. Primary objectives: 1. Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas. 2. Assess feasibility of Truvada procurement through the established Gilead access program 3. Evaluate adherence at week 12 and week 24 using dried blood spots Secondary objective: 1. Describe HIV incidence 2. Describe associations of positive and negative attitudes toward PrEP with acceptance of PrEP and subsequent adherence 3. Assess adherence at weeks 12 and 24 4. Evaluate the relationship between PrEP adherence and sexual activity 5. Compare geographic areas with respect to PrEP attitudes 6. Mentor junior investigators at each site.
Interventions
Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 - 64 years old * Able to give consent * "At risk" for HIV as defined by any of the following: 1. unprotected sex (in past 6 months) with 1 or more men of unknown HIV status 2. evaluated for an STI within 6 months prior to screening 3. sex in last 6 months with an HIV-infected partner 4. IDU with report of using previously used or shared needles in past 6 months or has been in a methadone, buprenorphine, or suboxone treatment program in past 6 months or engaging in high-risk sexual behaviors 5. individuals engaging in transactional sex (i.e sex for money, drugs, or housing) 6. Infrequently uses condoms during sex with 1 or more partners of unknown HIV status who are known to be at substantial risk of HIV infection (IDU or bisexual male partner) * CrCl ≥ 60 ml/min * HIV- uninfected women desiring PrEP
Exclusion criteria
* Active alcohol or drug use or dependence which may interfere with adherence to study requirements * HIV-infected at screening or enrollment * Estimated CrCl \< 60 mL/min * Past participation in an HIV vaccine study * Positive Hepatitis B surface antigen test * Underlying medical condition with survival unlikely during follow-up period * Any condition that in the opinion of study staff would make participation in the study unsafe or interfere with achieving study objectives * Pregnant or breast feeding * Actively trying to achieve pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots | 24 Weeks | Dried blood spot tenofovir-diphosphate levels were summarized using prespecified adherence threshold categories at week 12 and week 24. |
| PrEP Awareness and Interest Questionnaire Responses at Week 24 | 24 weeks | Assessment of participants' attitudes toward pre-exposure prophylaxis using questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Obtaining Truvada Via the Gilead Access Program | 24 Weeks | Evaluation of feasibility using logistic regression comparing the proportion of participants with tenofovir plasma levels \>0.3 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShobha Swaminathan, MD
New Jersey Medical School
Participant flow
Recruitment details
A total of 162 individuals were screened across four academic medical centers. Recruitment targeted individuals at risk for HIV through clinics, community outreach, and social media between the dates of September 2016 and April 2019.
Pre-assignment details
After providing informed consent, 11 participants did not proceed to assignment/initiation of study participation because they did not meet the eligibility criteria identified during screening procedures.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 18-24 years | 9 Participants |
| Age, Customized 25-44 years | 73 Participants |
| Age, Customized 45 years and older | 73 Participants |
| Age, Customized Unknown / No response | 7 Participants |
| Baseline HIV Risk Factors and Sexual Behavior Always discuss HIV with partners : | 66 Participants |
| Baseline HIV Risk Factors and Sexual Behavior History of STI : | 94 Participants |
| Baseline HIV Risk Factors and Sexual Behavior HIV-positive sexual partner : | 26 Participants |
| Baseline HIV Risk Factors and Sexual Behavior Multiple recent partners (3+ in 6 months) : | 69 Participants |
| Baseline HIV Risk Factors and Sexual Behavior Multiple sexual partners (11+ lifetime) : | 93 Participants |
| Baseline HIV Risk Factors and Sexual Behavior Never discuss HIV with partners : | 64 Participants |
| Baseline HIV Risk Factors and Sexual Behavior Recent HIV test (within 6 months) : | 108 Participants |
| Baseline HIV Risk Factors and Sexual Behavior Worry about getting HIV "all the time" : | 42 Participants |
| Baseline HIV Risk Factors and Sexual Behavior Worry about getting HIV "often" : | 41 Participants |
| Education College / technical school grad | 27 Participants |
| Education High school / GED | 50 Participants |
| Education Some college / tech school | 42 Participants |
| Education Unknown / No response | 43 Participants |
| Employment Status (screening) Currently Employed | 162 Participants |
| Employment Status (screening) Full-time homemaker | 8 Participants |
| Employment Status (screening) Full-time job | 21 Participants |
| Employment Status (screening) Full-time student | 3 Participants |
| Employment Status (screening) Part-time job | 16 Participants |
| Employment Status (screening) Unemployed | 114 Participants |
| HIV High-Risk Eligibility Criteria (Counts) Engagement in transactional sex | 90 Participants |
| HIV High-Risk Eligibility Criteria (Counts) History of STI evaluation (prior 6 months) | 63 Participants |
| HIV High-Risk Eligibility Criteria (Counts) HIV High-Risk Eligibility Criteria (Counts) | 162 Participants |
| HIV High-Risk Eligibility Criteria (Counts) IDU/Treatment program participation | 96 Participants |
| HIV High-Risk Eligibility Criteria (Counts) Infrequent condom use | 87 Participants |
| HIV High-Risk Eligibility Criteria (Counts) Sex with an HIV-infected partner | 121 Participants |
| HIV High-Risk Eligibility Criteria (Counts) Unprotected sex with 1+ men of unknown status | 26 Participants |
| Race/Ethnicity, Customized Black | 109 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants |
| Race/Ethnicity, Customized Other | 6 Participants |
| Race/Ethnicity, Customized White | 44 Participants |
| Region of Enrollment United States Atlanta | 42 Participants |
| Region of Enrollment United States Chicago | 52 Participants |
| Region of Enrollment United States Newark | 37 Participants |
| Region of Enrollment United States West Virginia | 31 Participants |
| Sex: Female, Male Female | 162 Participants |
| Sex: Female, Male Male | 0 Participants |
| Sexual Risk Behaviors Age at first intercourse <16 years | 111 Participants |
| Sexual Risk Behaviors Condom use (male/female condoms) | 63 Participants |
| Sexual Risk Behaviors Frequent sexual activity (3+ times/week) | 109 Participants |
| Sexual Risk Behaviors Use birth control | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 162 |
| other Total, other adverse events | 10 / 162 |
| serious Total, serious adverse events | 0 / 162 |
Outcome results
None listed