Trial Outcomes & Findings for Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV (NCT NCT00949234)

NCT ID: NCT00949234

Last Updated: 2017-12-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 267 participants
• Primary outcome timeframe: 24 Weeks
• Results posted on: 2017-12-18

Participant Flow

Two community-based sites, Jeffrey Goodman Clinic and The OASIS Clinic, will serve as facilities at which participants may present for screening for post-exposure prophylaxis services, as well as sexually transmitted diseases.

Participant milestones

Measure	PEP Group An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into "moderate behavioral risk," or "high behavioral risk." Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
Overall Study STARTED	267
Overall Study COMPLETED	225
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV

Baseline characteristics by cohort

Measure	PEP Group n=267 Participants An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into "moderate behavioral risk," or "high behavioral risk." Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	266 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	32 years n=5 Participants
Sex/Gender, Customized Male	253 participants n=5 Participants
Sex/Gender, Customized Female	11 participants n=5 Participants
Sex/Gender, Customized Transgender	3 participants n=5 Participants
Race/Ethnicity, Customized Black/AA	23 participants n=5 Participants
Race/Ethnicity, Customized White	128 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino(a)	92 participants n=5 Participants
Race/Ethnicity, Customized Asian	13 participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	1 participants n=5 Participants
Race/Ethnicity, Customized Other	10 participants n=5 Participants
Region of Enrollment United States	267 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Population: 254 individuals were exposed to HIV once and received PEP; 11 individuals were exposed to HIV twice and received a PEP regimen twice; and 2 were exposed to HIV three times and received a PEP regimen for each of the three exposures

Outcome measures

Measure	PEP Group n=282 HIV Exposure Events An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into "moderate behavioral risk," or "high behavioral risk." Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit Retained at 24 Weeks	125 HIV Exposure Events
Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit Not Retained at 24 Weeks	157 HIV Exposure Events

Adverse Events

PEP Group

Serious events: 0 serious events

Other events: 155 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PEP Group n=282 participants at risk An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into "moderate behavioral risk," or "high behavioral risk." Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
Gastrointestinal disorders Diarrhea	27.7% 78/282 • 24 Weeks Some individuals reenrolled in the study if an HIV exposure occurred at a later date. 254 individuals were exposed to HIV once and received PEP; 11 individuals were exposed to HIV twice and received a PEP regimen twice; and 2 were exposed to HIV three times and received a PEP regimen for each of the three exposures. A total of 282 PEP regimens were initiated on 267 unique individuals. 282 was used as the denominator for report Adverse Events.
Gastrointestinal disorders Nausea	17.0% 48/282 • 24 Weeks Some individuals reenrolled in the study if an HIV exposure occurred at a later date. 254 individuals were exposed to HIV once and received PEP; 11 individuals were exposed to HIV twice and received a PEP regimen twice; and 2 were exposed to HIV three times and received a PEP regimen for each of the three exposures. A total of 282 PEP regimens were initiated on 267 unique individuals. 282 was used as the denominator for report Adverse Events.
General disorders Fatigue	13.8% 39/282 • 24 Weeks Some individuals reenrolled in the study if an HIV exposure occurred at a later date. 254 individuals were exposed to HIV once and received PEP; 11 individuals were exposed to HIV twice and received a PEP regimen twice; and 2 were exposed to HIV three times and received a PEP regimen for each of the three exposures. A total of 282 PEP regimens were initiated on 267 unique individuals. 282 was used as the denominator for report Adverse Events.
Gastrointestinal disorders Mild to moderate abdominal discomfort	8.5% 24/282 • 24 Weeks Some individuals reenrolled in the study if an HIV exposure occurred at a later date. 254 individuals were exposed to HIV once and received PEP; 11 individuals were exposed to HIV twice and received a PEP regimen twice; and 2 were exposed to HIV three times and received a PEP regimen for each of the three exposures. A total of 282 PEP regimens were initiated on 267 unique individuals. 282 was used as the denominator for report Adverse Events.

Additional Information

Dr. Raphael Landovitz

UCLA CARE Center

Phone: 310-557-1891

Email: rlandovitz@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place