Phase 2 N=58 Randomized Triple-blind Prevention

Pre-Exposure Prophylaxis in YMSM

HIV

Bottom Line

View on ClinicalTrials.gov: NCT01033942 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Actual Number of Study Visits Completed by 24 Weeks — 3.5927; 4.6263; 4.6374 Visits — p=0.6983

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP (Drug); Placebo (Drug); Many Men, Many Voices (3MV) (Behavioral)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Actual Number of Study Visits Completed by 24 Weeks	3.5927; 4.6263; 4.6374	0.6983
PRIMARY Acceptability of Size of Pill	3; 3; 3; 3; 3; 6	0.6921
PRIMARY Acceptability of the Taste of the Pill	4; 3; 1; 4; 4; 5	0.4655
PRIMARY Acceptability of the Color of the Pill	1; 1; 2; 3; 4; 5	0.9999
PRIMARY Acceptability of Taking the Pill Everyday	3; 1; 3; 7; 2; 4	0.2297
PRIMARY Acceptability of Taking Part in the Study	2; 0; 0; 0; 1; 0	0.1886
PRIMARY Acceptability of Participating in Group Sessions	0; 1; 0; 1; 2; 0	0.1908
PRIMARY Acceptability of Being Randomly Assigned to a Group	1; 4; 0; 3; 2; 2	0.2240
PRIMARY Acceptability of Having an HIV Test at Every Visit	0; 1; 0; 0; 3; 1	0.1538
PRIMARY Acceptability of Risk Reduction Counseling at Every Visit	0; 1; 0; 1; 5; 4	0.2151
PRIMARY Acceptability of Questions About Sexual Behavior at Every Visit	0; 1; 0; 0; 1; 0	0.2809
PRIMARY Acceptability of Being Contacted by the Research Team in Between Visits	0; 2; 0; 4; 5; 3	0.1850
PRIMARY Acceptability of Physical Examination by a Doctor	0; 3; 0; 1; 0; 0	0.2366
PRIMARY Acceptability of Health Clinic for Study Visits	0; 2; 0; 4; 4; 3	0.4089
PRIMARY Number of Missed Doses Based on Self-Report Calendar Data-Week 4	10; 10	0.9999
PRIMARY Number of Missed Doses Based on Self-Report Calendar Data-Week 8	14; 8	0.9999
PRIMARY Number of Missed Doses Based on Self-Report Calendar Data-Week 12	10; 6.5	0.9999
PRIMARY Number of Missed Doses Based on Self-Report Calendar Data-Week 16	5; 19	0.7007
PRIMARY Number of Missed Doses Based on Self-Report Calendar Data-Week 20	5; 10	0.9999
PRIMARY Number of Missed Doses Based on Self-Report Calendar Data-Week 24	17; 5.5	0.9999
PRIMARY Number of Missed Doses Over Time Based on Self-Report Calendar Data	0.4752; 0.4021	0.8934
PRIMARY Number of Missed Doses Based on Medication Refill Dates-Week 4	0; 0	0.9999
PRIMARY Number of Missed Doses Based on Medication Refill Dates-Week 8	0; 0	0.9999
PRIMARY Number of Missed Doses Based on Medication Refill Dates-Week 12	0; 0	0.9999
PRIMARY Number of Missed Doses Based on Medication Refill Dates-Week 16	0; 0	0.4003
PRIMARY Number of Missed Doses Based on Medication Refill Dates-Week 20	0; 0	0.6462
PRIMARY Number of Missed Doses Based on Medication Refill Dates-Overall	0; 0	0.8505
PRIMARY Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline	0; 0	—
PRIMARY Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4	63.2; 0	—
PRIMARY Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8	47.1; 0; 0	—
PRIMARY Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12	60; 0; 0	—
PRIMARY Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16	53.8; 0; 0	—
PRIMARY Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20	41.7; 0	—
PRIMARY Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24	20	—
PRIMARY Frequency of Missing Study Pills Because Participant Was Away From Home	31.76; 48.39; 34.12; 20.43; 16.47; 26.88	0.7434
PRIMARY Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things	47.06; 58.06; 30.59; 16.13; 15.29; 21.51	0.6153
PRIMARY Frequency of Missing Study Pills Because Participant Simply Forgot	38.82; 60.22; 40.00; 16.13; 9.41; 15.05	0.2000
PRIMARY Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take	92.94; 95.70; 7.06; 2.15; 0.00; 1.08	0.5265
PRIMARY Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects	82.35; 91.40; 9.41; 3.23; 0.00; 2.15	0.2559
PRIMARY Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications	88.24; 92.47; 5.88; 4.30; 2.35; 0.00	0.3846
PRIMARY Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine	62.35; 70.97; 25.53; 15.05; 7.06; 10.75	0.5133
PRIMARY Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful	87.06; 95.70; 5.88; 2.15; 3.53; 0.00	0.1661
PRIMARY Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time	68.24; 86.02; 24.71; 6.45; 4.71; 4.30	0.0729
PRIMARY Frequency of Missing Study Pills Because Participant Felt Sick or Ill	81.18; 89.25; 11.76; 5.38; 4.71; 3.23	0.1912
PRIMARY Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed	83.53; 92.47; 12.94; 2.15; 0.00; 3.23	0.2829
PRIMARY Frequency of Missing Study Pills Because Participant Ran Out of Study Pills	94.12; 97.85; 4.71; 1.08; 0.00; 1.08	0.2685
PRIMARY Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex	90.59; 96.77; 4.71; 0.00; 1.18; 2.15	0.2342
PRIMARY Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4	9; 10; 4; 1; 5; 6	0.7314
PRIMARY Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8	8; 9; 5; 2; 4; 7	0.3770
PRIMARY Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12	6; 6; 3; 2; 5; 8	0.7004
PRIMARY Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16	6; 5; 2; 1; 4; 9	0.4668
PRIMARY Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20	4; 6; 3; 2; 4; 6	0.7573
PRIMARY Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24	2; 8; 3; 0; 4; 4	0.0356 sig
PRIMARY Perceived Risk of Becoming HIV Positive at Week 4	52.63; 38.89; 33.33; 21.05; 33.33; 22.22	0.3176
PRIMARY Perceived Risk of Becoming HIV Positive at Week 8	29.41; 66.67; 58.82; 17.65; 27.78; 11.76	0.1348
PRIMARY Perceived Risk of Becoming HIV Positive at Week 12	40.00; 75.00; 31.25; 40.00; 6.25; 37.50	0.0420 sig
PRIMARY Perceived Risk of Becoming HIV Positive at Week 16	58.33; 80.00; 42.86; 16.67; 13.33; 21.43	0.4906
PRIMARY Perceived Risk of Becoming HIV Positive at Week 20	66.67; 78.57; 30.77; 16.67; 21.43; 23.08	0.0544
PRIMARY Perceived Risk of Becoming HIV Positive at Week 24	60.00; 75.00; 38.46; 20.00; 8.33; 23.08	0.5645
PRIMARY Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	84.21; 83.33; 94.44; 5.26; 5.56; 0.00	0.7847
PRIMARY Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	68.75; 100.00; 64.71; 25.00; 0.00; 29.41	0.0288 sig
PRIMARY Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	60.00; 93.75; 68.75; 33.33; 0.00; 18.75	0.0945
PRIMARY Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	66.67; 93.33; 71.43; 25.00; 6.67; 7.14	0.3884
PRIMARY Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	91.67; 92.86; 61.54; 8.33; 7.14; 30.77	0.2235
PRIMARY Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	80.00; 91.67; 53.85; 20.00; 0.00; 23.08	0.0467 sig
PRIMARY Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	66.67; 55.56; 55.56; 5.56; 27.78; 11.11	0.6331
PRIMARY Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	47.06; 66.67; 35.29; 29.41; 5.56; 35.29	0.0948
PRIMARY Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	64.29; 68.75; 43.75; 0.00; 12.50; 18.75	0.5826
PRIMARY Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	53.85; 93.33; 42.86; 15.38; 0.00; 42.86	0.0087 sig
PRIMARY Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	75.00; 78.57; 38.46; 25.00; 7.14; 15.38	0.1934
PRIMARY Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	50.00; 83.33; 46.15; 30.00; 16.67; 15.38	0.2146
PRIMARY Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	63.16; 66.67; 55.56; 5.26; 16.67; 27.78	0.5317
PRIMARY Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	58.82; 66.67; 35.29; 17.65; 11.11; 23.53	0.1733
PRIMARY Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	73.33; 81.25; 43.75; 20.00; 6.25; 18.75	0.1747
PRIMARY Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	58.33; 80.00; 35.71; 33.33; 6.67; 21.43	0.1203
PRIMARY Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	66.67; 78.57; 53.85; 25.00; 14.29; 23.08	0.8243
PRIMARY Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	50.00; 83.33; 53.85; 30.00; 8.33; 15.38	0.6202
PRIMARY Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	57.89; 66.67; 50.00; 26.32; 22.22; 27.78	0.8351
PRIMARY Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	47.06; 83.33; 35.29; 23.53; 11.11; 41.18	0.0484 sig
PRIMARY Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	57.14; 81.25; 50.00; 28.57; 12.50; 18.75	0.4207
PRIMARY Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	75.00; 80.00; 42.86; 25.00; 6.67; 28.57	0.2187
PRIMARY Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	75.00; 92.86; 61.54; 16.67; 7.14; 23.08	0.5369
PRIMARY Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	60.00; 83.33; 46.15; 40.00; 16.67; 15.38	0.1524
PRIMARY Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	63.16; 50.00; 44.44; 5.26; 16.67; 5.56	0.4700
PRIMARY Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	52.94; 61.11; 23.53; 5.88; 11.11; 17.65	0.4686
PRIMARY Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	46.67; 68.75; 25.00; 13.33; 6.25; 25.00	0.3791
PRIMARY Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	46.15; 66.67; 42.86; 15.38; 6.67; 14.29	0.7374
PRIMARY Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	75.00; 71.43; 61.54; 8.33; 21.43; 15.38	0.9363
PRIMARY Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	50.00; 66.67; 30.77; 10.00; 16.67; 15.38	0.6267
SECONDARY Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline	11; 11; 12	0.8722
SECONDARY Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4	15; 14; 12	0.6434
SECONDARY Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8	10; 12; 10	0.8582
SECONDARY Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12	13; 14; 12	0.5778
SECONDARY Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16	11; 13; 12	0.9881
SECONDARY Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20	9; 11; 10	0.9771
SECONDARY Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24	9; 7; 10	0.2301

Summary

This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP). After completing the 3MV behavioral intervention, participants will be randomly assigned to one of three study arms: 1) daily FTC/TDF as PrEP, 2) placebo pill control, or 3) "no pill" control. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who decline to participate will be asked to complete a brief survey about their opinions on PrEP. Qualitative interviews will be completed with six study participants and the study coordinators at the end of the trial to explore further the issues of trial acceptability and feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability issues with YMSM who meet all eligibility requirements of the study except for not being age 18 or older, but are at least 16 years of age.

Eligibility Criteria

Inclusion Criteria

Willing and able to independently provide written informed consent;
Of male gender at birth;
Between the ages of 18 years and 0 days through 22 years and 364 days at the time of signed informed consent;
Self-reporting at least one episode of unprotected anal intercourse with a male within the last 12 months at the time of Personal Digital Assistant (PDA) Screening Interview;
Tests HIV negative at time of screening (using any FDA-approved HIV diagnostic test);
Willing to provide locator information to study staff;
Willing to be assigned to any of the three biomedical intervention conditions;
Does not report intention to relocate out of the study area during the course of the study; and
Does not have job/other obligations that would require long absences from the area (> 4 weeks at a time).

Exclusion Criteria

Transgender (behavioral intervention not targeted toward this population);
Presence of serious psychiatric symptoms (e.g., active hallucinations);
Visibly distraught at the time of consent (e.g., suicidal, homicidal, exhibiting violent behavior);
Intoxicated or under the influence of alcohol or other drugs at the time of consent;
Acute or chronic hepatitis B infection (exclude if hepatitis B surface antigen positive);
Renal dysfunction (Creatinine Clearance 2+] urine dipstick), unless explained by orthostatic proteinuria;
Confirmed glucosuria (repeated positive [> 1+] urine dipstick) in the presence of normal blood glucose (<120 mg/dL);
Any Grade 3 toxicity on screening tests/assessments;
Concurrent participation in an HIV vaccine study or other investigational drug study; or
Known allergy/sensitivity to the study drug or its components.
Use of disallowed medications

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Data sourced from ClinicalTrials.gov (NCT01033942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.