HIV InfectionsPhase 2ADAPTNCT01327651

The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)

A Phase 2 study testing Daily dosing, Time-driven dosing and Event-driven dosing in people with HIV Infections, run by HIV Prevention Trials Network at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will examine the feasibility of different methods of dosing for a PrEP regimen. Three methods of delivery will be compared: daily, time-based, and event-based. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Daily dosing, Time-driven dosing and Event-driven dosing
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 622 participants
Where: 3 sitesin 3 countries
Study dates: Aug 2011to Dec 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Literacy in one of the study languages (Thai, Xhosa, and/or English)
Able to provide written informed consent
Able to provide weekly telephonic updates
Within 70 days of enrollment:
Serum creatinine less than or equal to the upper limit of normal (ULN) and calculated creatinine clearance of at least 70 mL/min by the Cockcroft-Gault formula. More information on this criterion can be found in the protocol.
Serum phosphate greater than or equal to the lower limit of normal (LLN)

Show all 18Show fewer

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2 times ULN
Hemoglobin greater than 10 g/dL
Hepatitis B surface antigen (HBsAg)-negative
Willing and able to provide adequate locator information
Male at birth
Reporting anal intercourse and/or receptive neovaginal intercourse with at least one man or transgender woman in the past 6 months
One or more of the following risk factors for HIV acquisition in the past 6 months according to self-report: sexual intercourse with more than one man or transgender woman; history of an acute sexually transmitted infection (STI); sex in exchange for money, goods, or favors; condomless intercourse (oral, anal, vaginal, or neovaginal) with a partner known to be HIV-infected or of unknown HIV infection status according to self report
Female at birth or self identify as female
Not pregnant or breastfeeding
Not able to or not intending to become pregnant during the next year
If able to become pregnant, self reported use of an effective method of contraception at Enrollment, and intending to use an effective method for the next 34 weeks
One or more of the following risk factors for HIV acquisition in the past 6 months according to self report: sexual intercourse with more than one man; history of an acute STI; sex in exchange for money, goods or favors; condomless intercourse (oral, anal, or vaginal) with a partner known to be HIV-infected or of unknown HIV infection status

Who cannot join

Proteinuria 2+ or greater at screening
Glucosuria 2+ or greater at screening
Serious and active medical or mental illness
One or both HIV rapid tests is reactive at screening or enrollment, regardless of subsequent HIV diagnostic test results
Signs or symptoms suggestive of acute HIV infection
Use of hypoglycemic agents for diabetes or agents with known nephrotoxic potential

Show all 13Show fewer

Use of ARV therapy (e.g., for post-exposure prophylaxis [PEP] or PrEP) in the 90 days prior to study entry
Serum phosphate level below site laboratory LLN
Current participation (or participation within 3 months of screening) in any HIV prevention study
Previous or current participation in the active arm of an HIV vaccine trial
Acute or chronic hepatitis B (HBV) infection (refers to chronic active HBV infection evidenced by a positive test for hepatitis B surface antigen (HBsAg)
Presence of a psychological or social condition or an addictive disorder that would preclude compliance with the protocol
Any other reason or condition that in the opinion of the investigator would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

United States1 site

Harlem Prevention Center CRS
New York, New York, 10027

Other trials in United States

South Africa1 site

Emavundleni CRS
Cape Town, Western Cape, 7750

Other trials in South Africa

Thailand1 site

Silom Community Clinic CRS
Nonthaburi, 11000

Other trials in Thailand

About this study

Official title: The ADAPT Study: A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) Pre-Exposure Prophylaxis (PrEP)

Read the detailed description

No single strategy for the prevention of HIV has emerged as consistently used and successful, so multiple strategies have been developed. PrEP involves delivering ARV medications to people before they are exposed to HIV, in order to prevent infection. The optimal method of delivering PrEP has not yet been determined. This study will examine the feasibility of delivering PrEP in three methods. Daily dosing involves receiving ARV medications every day; time-driven dosing involves receiving ARV medications twice weekly plus a post-exposure dose; and event-driven dosing involves receiving ARV medications before and after a potential exposure to HIV. The ARV medication that will be used in this study is a combination pill that contains emtricitabine and tenofovir disoproxil fumarate (FTC/TDF). Recent research studies have shown that, if taken consistently, a daily oral dose of FTC/TDF can reduce the risk of HIV infection.

This study will enroll HIV-uninfected men who have sex with men and transgender women (MSM/TGW) and women who have sex with men (WSM). Participation will last 34 weeks. All participants will be given a combination pill that contains FTC/TDF. For the first 5 weeks, all participants will come to the study clinic weekly to receive a single dose of FTC/TDF.

At Week 6, participants will be randomly assigned to one of three groups. In the daily dosing group, participants will take FTC/TDF once a day. In the time-dosing group, participants will take FTC/TDF twice per week and another dose after sexual intercourse (a post-exposure dose). In the event-dosing group, participants will take FTC/TDF before and after sexual intercourse. During this part of the study, participants will be given FTC/TDF to take on their own. Every week, from Week 6 to Week 29, study officials will call to ask questions about how many pills participants have taken and when they have had sexual intercourse. Participants will also complete computer-assisted self-interviews (CASIs).

Study visits will occur at enrollment, once a week for the first 5 weeks, and then once a month until Week 34. Assessment will include recording of medical history, completing an interview about sexual practices and background, and collection of blood, urine, and hair samples. Select study visits will include vaginal practices assessment (including use of lubricants and vaginal cleansing practices), family planning assessments (for women), and sex hormones assessments (for men).

Participants who acquire HIV infection during the study will discontinue study product. These participants will continue to be followed after enrollment at Weeks 4, 6, 10, 14, 18, 22, 26, 30, and every 12 weeks thereafter, as appropriate, until the last study participant completes follow-up at the study site. Participants whose first reactive HIV rapid test is at Week 34 who are later confirmed to be HIV infected will also be followed every 12 weeks after their Week 30 visit until the last study participant completes follow-up at the study site. Participants who acquire HIV infection during the study will undergo select protocol procedures and will receive counseling and referrals for HIV treatment.

Conditions: HIV Infections
Being tested: Daily dosing, Time-driven dosing, Event-driven dosing
Keywords: Drug Administration Schedule, Nucleoside Reverse Transcriptase Inhibitors, Pharmacokinetics
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Daily dosingDrug
Also called Daily, TDF/FTC
A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.
Time-driven dosingDrug
Also called A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.
TDF/FTC twice weekly with a post-exposure dose
Event-driven dosingDrug
Also called A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.
TDF/FTC as needed with a post exposure dose

Study groups in NCT01327651
Study group	Role	What they receive
Daily dosing	Active comparator	Participants will receive oral FTC/TDF daily. Receives: Drug: Daily dosing
Time-driven dosing	Experimental	Participants will receive oral FTC/TDF twice weekly with a post-exposure dose. Receives: Drug: Time-driven dosing
Event-driven dosing	Experimental	Participants will receive oral FTC/TDF before and after a potential exposure to HIV infection. Receives: Drug: Event-driven dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm.
Measured: From week 6 (randomization week) to week 30 (end of self-administered dosing)
The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)
Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are "covered"; Note: sex act is considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)
Measured: From week 6 (randomization week) to week 30 (end of self-administered dosing)
The Total Pills Actually Used Over the Follow-up Period
The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design
Measured: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Self-reported Side Effect or Symptom Scores
The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects
Measured: From week 6 (randomization week) to week 30 (end of self-administered dosing)

Secondary outcomes (8)

Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)
Below we presented the percentages of total cohort with TFV-DP concentrations consistent with >=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC >5.2 fmol/10^6 cells is considered as participants taken >=2 tablets per week; DBS >=326 fmol/punch is considered as participants taken >=2 tablets per week
Measured: week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product
Measured: From week 6 (randomization week) to week 30 (end of self-administered dosing)
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study.
Measured: From enrollment to week 30 (end of self-administered dosing)
The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data
Measured: From week 6 (randomization week) to week 30 (end of self-administered dosing)
The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews
Measured: From Week 6 to Week 30
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm.
Measured: From week 6 (randomization week) to week 30 (end of self-administered dosing)
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm.
Measured: From Enrollment to week 30 (end of self-administered dosing)
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels
Measured: From Enrollment to week 30 (end of self-administered dosing)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Dec 2014

First posted1 Apr 2011 (estimated)
Study startAug 2011
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: One arm is daily TDF/FTC. One arm is twice weekly TDF/FTC with a post-exposure dose. One arm is as needed TDF/FTC with a post-exposure dose.
Masking: None (open label)
Enrolment: 622 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01327651
Sponsor's protocol ID: HPTN 067 (ADAPT)
Other IDs: 10852
Acronym: ADAPT
Status last verified: Mar 2025
First submitted: 1 Dec 2010
Last updated: 27 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas 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.
PubMed 21091279
Hughes JP, Williamson BD, Krakauer C, Chau G, Ortiz B, Wakefield J, Hendrix C, Amico KR, Holtz TH, Bekker LG, Grant R. Combining information to estimate adherence in studies of pre-exposure prophylaxis for HIV prevention: Application to HPTN 067. Stat Med. 2022 Mar 15;41(6):1120-1136. doi: 10.1002/sim.9321. Epub 2022 Jan 25.
PubMed 35080038
Holtz TH, Chitwarakorn A, Hughes JP, Curlin ME, Varangrat A, Li M, Amico KR, Mock PA, Grant RM; Thai HPTN 067/ADAPT Study Team. HPTN 067/ADAPT: Correlates of Sex-Related Pre-exposure Prophylaxis Adherence, Thai Men Who Have Sex With Men, and Transgender Women, 2012-2013. J Acquir Immune Defic Syndr. 2019 Oct 1;82(2):e18-e26. doi: 10.1097/QAI.0000000000002131.
PubMed 31490342
Grant RM, Mannheimer S, Hughes JP, Hirsch-Moverman Y, Loquere A, Chitwarakorn A, Curlin ME, Li M, Amico KR, Hendrix CW, Anderson PL, Dye BJ, Marzinke MA, Piwowar-Manning E, McKinstry L, Elharrar V, Stirratt M, Rooney JF, Eshleman SH, McNicholl JM, van Griensven F, Holtz TH. Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study. Clin Infect Dis. 2018 May 17;66(11):1712-1721. doi: 10.1093/cid/cix1086.
PubMed 29420695
Bekker LG, Roux S, Sebastien E, Yola N, Amico KR, Hughes JP, Marzinke MA, Hendrix CW, Anderson PL, Elharrar V, Stirratt M, Rooney JF, Piwowar-Manning E, Eshleman SH, McKinstry L, Li M, Dye BJ, Grant RM; HPTN 067 (ADAPT) study team. Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial. Lancet HIV. 2018 Feb;5(2):e68-e78. doi: 10.1016/S2352-3018(17)30156-X. Epub 2017 Oct 3.
PubMed 28986029

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The ADAPT Study: A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) Pre-Exposure Prophylaxis (PrEP)
ClinicalTrials.gov ID: NCT01327651
Acronym / sponsor ID: ADAPT / HPTN 067 (ADAPT)
Conditions: HIV Infections
Keywords: Drug Administration Schedule, Nucleoside Reverse Transcriptase Inhibitors, Pharmacokinetics
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 622 participants (actual)
Lead sponsor: HIV Prevention Trials NetworkResearch network
Study start: Aug 2011
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 1 Apr 2011 (estimated)
Results: Posted 12 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: One arm is daily TDF/FTC. One arm is twice weekly TDF/FTC with a post-exposure dose. One arm is as needed TDF/FTC with a post-exposure dose.

Arm	Type	Receives
Daily dosing	Active comparator	Drug: Daily dosingParticipants will receive oral FTC/TDF daily.
Time-driven dosing	Experimental	Drug: Time-driven dosingParticipants will receive oral FTC/TDF twice weekly with a post-exposure dose.
Event-driven dosing	Experimental	Drug: Event-driven dosingParticipants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Literacy in one of the study languages (Thai, Xhosa, and/or English)
Able to provide written informed consent
Able to provide weekly telephonic updates
Within 70 days of enrollment:
Male at birth

Key exclusion criteria (13 listed)

Proteinuria 2+ or greater at screening
Glucosuria 2+ or greater at screening
Serious and active medical or mental illness
One or both HIV rapid tests is reactive at screening or enrollment, regardless of subsequent HIV diagnostic test results
Signs or symptoms suggestive of acute HIV infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Daily dosingAlso: Daily, TDF/FTCA fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.	Drug	Daily dosing
Time-driven dosingAlso: A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.TDF/FTC twice weekly with a post-exposure dose	Drug	Time-driven dosing
Event-driven dosingAlso: A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.TDF/FTC as needed with a post exposure dose	Drug	Event-driven dosing

Primary outcome

Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm.
The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are "covered"; Note: sex act is considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)
The Total Pills Actually Used Over the Follow-up Period
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design
Self-reported Side Effect or Symptom Scores
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects

8 secondary outcomes

Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)
Time frame: week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Time frame: From enrollment to week 30 (end of self-administered dosing)
The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews
Time frame: From Week 6 to Week 30
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Time frame: From Enrollment to week 30 (end of self-administered dosing)
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Time frame: From Enrollment to week 30 (end of self-administered dosing)

Results and safety

Results posted to the registry on 12 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Daily Dosing, Cape Town	60	56
Time-driven Dosing, Cape Town	59	56
Event-driven Dosing, Cape Town	60	56
Daily Dosing, Bangkok	60	57
Time-driven Dosing, Bangkok	59	56
Event-driven Dosing, Bangkok	59	59
Daily Dosing, Harlem	59	49
Time-driven Dosing, Harlem	60	50
Event-driven Dosing, Harlem	60	49

Primary outcome: Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing

Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing). Number. Unit: percentage of sexual exposures

Measure	Daily Dosing, Cape Town n = 59	Time-driven Dosing, Cape Town n = 59	Event-driven Dosing, Cape Town n = 60	Daily Dosing, Bangkok n = 60	Time-driven Dosing, Bangkok n = 59	Event-driven Dosing, Bangkok n = 59	Daily Dosing, Harlem n = 59	Time-driven Dosing, Harlem n = 60	Event-driven Dosing, Harlem n = 60
% completely covered	75	56	52	85	84	74	66	47	52
% pre-exposure coverage	21	30	33	11	12	19	24	30	29
% post-exposure coverage	1	9	8	1	3	5	2	8	6
% uncovered	3	5	7	3	1	3	8	15	13

Population analysed: For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm

Primary outcome: The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)

Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing). Number. Unit: Number of pills needed for 100% coverage

Measure	Daily Dosing, Cape Town n = 59	Time-driven Dosing, Cape Town n = 59	Event-driven Dosing, Cape Town n = 60	Daily Dosing, Bangkok n = 60	Time-driven Dosing, Bangkok n = 59	Event-driven Dosing, Bangkok n = 59	Daily Dosing, Harlem n = 59	Time-driven Dosing, Harlem n = 60	Event-driven Dosing, Harlem n = 60
Value	2097	1552	1906	1746	1573	1268	1244	1390	1582

Primary outcome: The Total Pills Actually Used Over the Follow-up Period

Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing). Number. Unit: Number of pills actually used

Measure	Daily Dosing, Cape Town n = 59	Time-driven Dosing, Cape Town n = 59	Event-driven Dosing, Cape Town n = 60	Daily Dosing, Bangkok n = 60	Time-driven Dosing, Bangkok n = 59	Event-driven Dosing, Bangkok n = 59	Daily Dosing, Harlem n = 59	Time-driven Dosing, Harlem n = 60	Event-driven Dosing, Harlem n = 60
Value	7349	2852	2000	8285	3713	2157	5507	2468	2356

Primary outcome: Self-reported Side Effect or Symptom Scores

Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing). Number. Unit: percent of visits between week 6 to 30

Measure	Daily Dosing, Cape Town n = 59	Time-driven Dosing, Cape Town n = 59	Event-driven Dosing, Cape Town n = 60	Daily Dosing, Bangkok n = 60	Time-driven Dosing, Bangkok n = 59	Event-driven Dosing, Bangkok n = 59	Daily Dosing, Harlem n = 59	Time-driven Dosing, Harlem n = 60	Event-driven Dosing, Harlem n = 60
Neurologic side effect	12.4	6.0	7.8	14.2	14.3	13.3	6.1	3.3	4.5
Gastrointestinal side effects	10.6	8.8	5.4	13.1	8.5	10.5	8	5.8	7.1

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daily Dosing, Cape Town	1 of 59 (1.7%)	59 of 59 (100%)	Not reported
Time-driven Dosing, Cape Town	0 of 59 (0%)	59 of 59 (100%)	Not reported
Event-driven Dosing, Cape Town	2 of 60 (3.3%)	59 of 60 (98.3%)	Not reported
Daily Dosing, Bangkok	5 of 60 (8.3%)	58 of 60 (96.7%)	Not reported
Time-driven Dosing, Bangkok	1 of 59 (1.7%)	59 of 59 (100%)	Not reported
Event-driven Dosing, Bangkok	3 of 59 (5.1%)	58 of 59 (98.3%)	Not reported
Daily Dosing, Harlem	3 of 59 (5.1%)	53 of 59 (89.8%)	Not reported
Time-driven Dosing, Harlem	6 of 60 (10%)	55 of 60 (91.7%)	Not reported
Event-driven Dosing, Harlem	1 of 60 (1.7%)	54 of 60 (90%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21091279Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas 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.
Derived from this study: PubMed 35080038Hughes JP, Williamson BD, Krakauer C, Chau G, Ortiz B, Wakefield J, Hendrix C, Amico KR, Holtz TH, Bekker LG, Grant R. Combining information to estimate adherence in studies of pre-exposure prophylaxis for HIV prevention: Application to HPTN 067. Stat Med. 2022 Mar 15;41(6):1120-1136. doi: 10.1002/sim.9321. Epub 2022 Jan 25.
Derived from this study: PubMed 31490342Holtz TH, Chitwarakorn A, Hughes JP, Curlin ME, Varangrat A, Li M, Amico KR, Mock PA, Grant RM; Thai HPTN 067/ADAPT Study Team. HPTN 067/ADAPT: Correlates of Sex-Related Pre-exposure Prophylaxis Adherence, Thai Men Who Have Sex With Men, and Transgender Women, 2012-2013. J Acquir Immune Defic Syndr. 2019 Oct 1;82(2):e18-e26. doi: 10.1097/QAI.0000000000002131.
Derived from this study: PubMed 29420695Grant RM, Mannheimer S, Hughes JP, Hirsch-Moverman Y, Loquere A, Chitwarakorn A, Curlin ME, Li M, Amico KR, Hendrix CW, Anderson PL, Dye BJ, Marzinke MA, Piwowar-Manning E, McKinstry L, Elharrar V, Stirratt M, Rooney JF, Eshleman SH, McNicholl JM, van Griensven F, Holtz TH. Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study. Clin Infect Dis. 2018 May 17;66(11):1712-1721. doi: 10.1093/cid/cix1086.
Derived from this study: PubMed 28986029Bekker LG, Roux S, Sebastien E, Yola N, Amico KR, Hughes JP, Marzinke MA, Hendrix CW, Anderson PL, Elharrar V, Stirratt M, Rooney JF, Piwowar-Manning E, Eshleman SH, McKinstry L, Li M, Dye BJ, Grant RM; HPTN 067 (ADAPT) study team. Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial. Lancet HIV. 2018 Feb;5(2):e68-e78. doi: 10.1016/S2352-3018(17)30156-X. Epub 2017 Oct 3.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert M. Grant, MD, MPH study chair

University of California, San Francisco

Frits van Griensven, PhD, MPH study chair

School of Medicine, University of California at San Francisco

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daily dosing, Time-driven dosing and Event-driven dosing in people with HIV Infections, run by HIV Prevention Trials Network at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, South Africa, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing (time frame: From week 6 (randomization week) to week 30 (end of self-administered dosing)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01327651, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.