Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT01632995
• Collaborator: (none)
• Enrollment: 557
• Locations: 3
• Arm: 1
• Duration (Months): 28
• Patients Per Site: 185.7
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), administered at sexually transmitted disease (STD) clinics and a community health center in the United States.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: FTC 200 mg/TDF 300 mg fixed-dose combination tablet	N/A

Detailed Description

A previous study (iPrEx) showed that daily PrEP with FTC/TDF provided with a comprehensive package of prevention services is effective in preventing HIV infection among men who have sex with men (MSM). The PrEP administered in that study was given in the context of a research setting/controlled trial, but it is important to evaluate the acceptability, sustainability, and safety of PrEP in a "real world" setting. This study will evaluate PrEP administered to HIV-uninfected MSM and transgender females at two STD clinics and one community health center in the United States.

Each participant will receive PrEP for up to 1 year and will have up to 8 study visits. PrEP will consist of one fixed-dose FTC/TDF combination tablet orally each day. All participants will have study visits at screening, enrollment, and 4 weeks after enrollment; participants will continue to have visits at Weeks 12, 24, 36, 48, and 52 if they do not seroconvert. Participants who seroconvert will discontinue PrEP and will have a post-drug discontinuation visit 4 weeks after discontinuing PrEP. At most visits, participants will undergo blood, urine, and hair sample collection; give a medical history; undergo a physical exam; receive risk-reduction counseling and condoms; undergo testing for HIV and other STDs; receive study drugs; and undergo a pill count and adherence assessment (follow-up visits only). For participants who stop taking the study drug but remain in the study, urine, blood, and hair samples will not be collected at 12-week follow-up visits if all stop procedures have been completed and if there are no lab abnormalities that require additional follow-up. Participants will also answer questionnaires at screening, 12-week visits, and at study exit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 557 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Implementation of HIV Pre-exposure Prophylaxis (PrEP): A Demonstration Project
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.	Drug: FTC 200 mg/TDF 300 mg fixed-dose combination tablet; Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.; Other Names: Truvada

Outcome Measures

Primary Outcome Measures

1. Measurement of Acceptance Rate of PrEP [Measured through enrollment (Week 0)]

2. Measurement of Refusal Rate of PrEP [Measured through enrollment (Week 0)]

3. Duration of PrEP Use [Participants were followed for 48 weeks, or up to the point of early termination]

   Number of study drug interruptions

4. Duration of PrEP Use [Participants were followed for 48 weeks, or up to the point of early termination]

   Mean duration of interruptions

5. Measurement of Side Effects/Toxicities [Participants were followed for 48 weeks, or up to the point of early termination]

6. Measurement of PrEP Adherence by TFV-DP Levels in DBS [Participants were followed for 48 weeks, or up to the point of early termination]

7. Number of Male Sexual Partners [Participants were followed for 48 weeks, or up to the point of early termination]

8. Measurement of PrEP Adherence by Medication Possession Ratio [Participants were followed for 48 weeks, or up to the point of early termination]

   Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits

Secondary Outcome Measures

1. Number of Participants Who Seroconvert [Participants were followed for 48 weeks, or up to the point of early termination]

2. Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected [Participants were followed for 48 weeks, or up to the point of early termination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Must be either a man who has sex with men or a transgender female

• Male sex (at birth)

• Willing and able to provide written informed consent

• HIV-1 uninfected, defined as having a negative rapid HIV antibody test at both screening visit and enrollment and a negative 4th generation antibody/antigen test at screening

• No laboratory evidence of a detectable HIV viral load (San Francisco site only)

• Evidence of risk of acquiring HIV-1 infection including any one of the following:

(1) Condomless anal sex with two or more male or transgender female sex partners during the last 12 months; or (2) two or more episodes of anal sex with at least one HIV-positive partner during the last 12 months; or (3) sex with a male or transgender female partner and any of the following STDs diagnosed during the last 12 months or at screening: syphilis, rectal gonorrhea, or rectal chlamydia.

• Able to provide a street address of residence or phone number for themselves or two personal contacts who would know their whereabouts during the period of the demonstration project

• Adequate renal function: creatinine clearance of 60 ml/min or greater as estimated by the Cockcroft-Gault equation within 45 days of enrollment

• A urine dipstick with a negative or trace result for protein within 45 days of enrollment

• Fluent in English or in Spanish

Exclusion Criteria:

• Signs or symptoms of acute HIV infection

• Previously diagnosed active and serious infections including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy (other than STDs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly controlled cardiac disease (e.g., symptoms of ischemia or congestive heart failure) or previously diagnosed malignancy expected to require further treatment

• Hepatitis B surface antigen (HBsAg) positive

• History of pathological bone fractures not related to trauma

• Receiving ongoing therapy with any of the following: investigational antiretroviral agents (PEP is allowed as described in the protocol), interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents

• Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents

• At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SF City Clinic Non-Network CRS	San Francisco	California	United States	94103
2	Whitman Walker Non-network CRS	Washington	District of Columbia	United States	20009
3	Miami PrEP Non-Network CRS	Miami	Florida	United States	33136

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Albert Liu, MD, MPH, San Francisco Department of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

• Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapía M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernández T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallás EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT01632995
• Other Study ID Numbers: PrEP Demonstration Project; 11879
• First Posted: Jul 4, 2012
• Last Update Posted: Nov 5, 2021
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: HIV Infections; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Study Results

Participant Flow

Recruitment Details	Participants were screened and enrolled at 3 sites in the US (San Francisco, Miami, Washington DC). Enrollment began on October 1, 2012 and ended February 10, 2015.
Pre-assignment Detail	As this PrEP Demonstration project assessed acceptance of PrEP, all participants assessed for participation are included in the "start" category, and those who enrolled and initiated PrEP are indicated as a separate milestone.

Arm/Group Title	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Arm/Group Description	All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
Period Title: Pre-screening to Enrollment Period
STARTED	1069
COMPLETED	557
NOT COMPLETED	512
Period Title: Pre-screening to Enrollment Period
STARTED	557
COMPLETED	437
NOT COMPLETED	120

Baseline Characteristics

Arm/Group Title	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Arm/Group Description	All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
Overall Participants	557
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	33
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	557 100%
Race/Ethnicity, Customized (Count of Participants)
White	266 47.8%
Latino	192 34.5%
Black	40 7.2%
Asian	26 4.7%
Other	32 5.7%
Region of Enrollment (participants) [Number]
United States	557 100%

Outcome Measures

1. Primary Outcome

Title	Measurement of Acceptance Rate of PrEP
Time Frame	Measured through enrollment (Week 0)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants Assessed for Participation
Arm/Group Description	All participants who were assessed for study participation
Measure Participants	1069
Potentially eligible clients	921 165.4%
Participants enrolled	557 100%

2. Primary Outcome

Title	Measurement of Refusal Rate of PrEP
Time Frame	Measured through enrollment (Week 0)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants Assessed for Participation
Arm/Group Description	All participants who were assessed for study participation
Measure Participants	1069
Potentially eligible clients	921 165.4%
Declined participation	364 65.4%

3. Primary Outcome

Title	Duration of PrEP Use
Description	Number of study drug interruptions
Time Frame	Participants were followed for 48 weeks, or up to the point of early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Arm/Group Description	All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
Measure Participants	557
Number [interruptions]	86

4. Primary Outcome

Title	Duration of PrEP Use
Description	Mean duration of interruptions
Time Frame	Participants were followed for 48 weeks, or up to the point of early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Arm/Group Description	All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
Measure Participants	557
Number [Days]	65

5. Primary Outcome

Title	Measurement of Side Effects/Toxicities
Time Frame	Participants were followed for 48 weeks, or up to the point of early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Arm/Group Description	All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
Measure Participants	557
Serious adverse events	19
Creatinine elevations	23

6. Primary Outcome

Title	Measurement of PrEP Adherence by TFV-DP Levels in DBS
Time Frame	Participants were followed for 48 weeks, or up to the point of early termination

Outcome Measure Data

Analysis Population Description

DBS testing was performed in approximately 100 randomly selected participants per site, and among all African American and transgender participants, who were underrepresented in the overall sample

Arm/Group Title	Participants With DBS Testing
Arm/Group Description	All study participants who had at least 1 DBS result
Measure Participants	294
% with protective TFV-DP levels at week 4	86 15.4%
% with protective TFV-DP levels at week 12	85 15.3%
% with protective TFV-DP levels at week 24	82 14.7%
% with protective TFV-DP levels at week 36	85 15.3%
% with protective TFV-DP levels at week 48	80 14.4%

7. Primary Outcome

Title	Number of Male Sexual Partners
Time Frame	Participants were followed for 48 weeks, or up to the point of early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Arm/Group Description	All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
Measure Participants	557
Mean Anal sex partners at baseline	10.9
Mean Anal sex partners at week 48	9.3

8. Primary Outcome

Title	Measurement of PrEP Adherence by Medication Possession Ratio
Description	Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits
Time Frame	Participants were followed for 48 weeks, or up to the point of early termination

Outcome Measure Data

Analysis Population Description

Mean PrEP adherence by medication possession ratio

Arm/Group Title	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Arm/Group Description	All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
Measure Participants	557
Number [percent]	85.9

9. Secondary Outcome

Title	Number of Participants Who Seroconvert
Time Frame	Participants were followed for 48 weeks, or up to the point of early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Arm/Group Description	All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
Measure Participants	557
Acute HIV infection at baseline	3 0.5%
HIV seroconversion during follow-up	2 0.4%

10. Secondary Outcome

Title	Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected
Time Frame	Participants were followed for 48 weeks, or up to the point of early termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Arm/Group Description	All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
Measure Participants	557
Number [participant with acquired HIV resistance]	1

Adverse Events

Arm/Group Title	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Arm/Group Description	All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
All Cause Mortality
	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
	Affected / at Risk (%)	# Events
Total	19/557 (3.4%)
Cardiac disorders
Atrial Fibrillation	1/557 (0.2%)	1
Gastrointestinal disorders
Appendicitis	1/557 (0.2%)	1
colitis	1/557 (0.2%)	1
Diarrhea	1/557 (0.2%)	1
Large intestine perforation	1/557 (0.2%)	1
General disorders
Hypertension / Hypertensive crisis	2/557 (0.4%)	2
Hepatobiliary disorders
Cholecystitis	1/557 (0.2%)	1
Immune system disorders
Food allergy	1/557 (0.2%)	1
Injury, poisoning and procedural complications
Overdose	1/557 (0.2%)	1
Testicular torsion	1/557 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	1/557 (0.2%)	1
Psychiatric disorders
suicidal ideation and/or attempt, bipolar disorder, or anxiety	8/557 (1.4%)	8
Other (Not Including Serious) Adverse Events
	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
	Affected / at Risk (%)	# Events
Total	25/557 (4.5%)
Injury, poisoning and procedural complications
Bone fracture	12/557 (2.2%)	12
Investigations
Creatinine elevation	13/557 (2.3%)	23

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.