Trial Outcomes & Findings for Packaging PrEP to Prevent HIV Among WWID (NCT NCT03304912)

Last Updated: 2023-07-12

Results Overview

Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.

Recruitment status

COMPLETED

Target enrollment

105 participants

Primary outcome timeframe

1 week

Results posted on

2023-07-12

Participant Flow

10 participants were withdrawn following enrollment because we were unable to draw blood in order to be able to prescribe PrEP medication.

Participant milestones

Participant milestones
Measure	Women Who Inject Drugs (WWID) Who Are Eligible for Pre-exposure Prophylaxis (PrEP) The cohort will be comprised of WWID who are eligible for PrEP. PrEP Education and option to accept a PrEP prescription: Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).
Overall Study STARTED	95
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	53

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Packaging PrEP to Prevent HIV Among WWID

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PrEP Education and Option to Accept a PrEP Prescription n=95 Participants Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	95 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	84 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment United States	95 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Of the 95 WWID who were offered a PrEP prescription, 89 women returned at week 1.

Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.

Outcome measures

Outcome measures
Measure	PrEP Education and Option to Accept a PrEP Prescription n=89 Participants Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP.
PrEP Uptake at Week 1	63 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Number of WWID returning to care at week 12.

Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.

Outcome measures

Outcome measures
Measure	PrEP Education and Option to Accept a PrEP Prescription n=59 Participants Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP.
PrEP Uptake at Week 12	48 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Women with available urine-analysis data that self-reported PrEP use at 3-months

Protection effective emtricitabine (FTC) concentration (\>1000 ng/ml) in urine. Analyzed only among women with available urine-analysis data that self-reported PrEP use at 12 weeks

Outcome measures

Outcome measures
Measure	PrEP Education and Option to Accept a PrEP Prescription n=20 Participants Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP.
PrEP Adherence Based on Urinalysis at 12 Weeks	1 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Number of women responding to adherence measure on survey

Self-reported adherence was assessed with a single item administered on a computer assisted self-interview. The item, "How many PrEP pills have you missed in the past 7 days?," had numerical response options ranging from zero to seven. Responses were recoded into: took zero doses within 7 days (operationalized as non-adherent), took 1-5 doses within 7 days defined as inconsistent operationalized), and took 6-7 doses within 7 days (operationalized as consistent adherence).

Outcome measures

Outcome measures
Measure	PrEP Education and Option to Accept a PrEP Prescription n=51 Participants Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP.
PrEP Adherence Based on Self-report at 12 Weeks Non-adherence	18 Participants
PrEP Adherence Based on Self-report at 12 Weeks Inconsistent-adherence	9 Participants
PrEP Adherence Based on Self-report at 12 Weeks Adherence	24 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Number of women returning to care at week 24

Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.

Outcome measures

Outcome measures
Measure	PrEP Education and Option to Accept a PrEP Prescription n=42 Participants Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP.
PrEP Uptake at Week 24	25 Participants

Adverse Events

Women Who Inject Drugs (WWID) Who Are Eligible for PrEP.

Serious events: 3 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Women Who Inject Drugs (WWID) Who Are Eligible for PrEP. n=95 participants at risk The cohort will be comprised of women who inject drugs who are eligible for PrEP. PrEP Education and option to accept a PrEP prescription: Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).
General disorders Hospitalization	3.2% 3/95 • Number of events 3 • 6 months The definitions of adverse events and serious adverse events did not differ from the clinicaltrials.gov.

Other adverse events

Other adverse events
Measure	Women Who Inject Drugs (WWID) Who Are Eligible for PrEP. n=95 participants at risk The cohort will be comprised of women who inject drugs who are eligible for PrEP. PrEP Education and option to accept a PrEP prescription: Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).
General disorders Victimization	9.5% 9/95 • Number of events 9 • 6 months The definitions of adverse events and serious adverse events did not differ from the clinicaltrials.gov.

Additional Information

Alexis Roth, PhD, MPH

Drexel University

Phone: 267.359.6123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place