Trial Outcomes & Findings for IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project (NCT NCT03058835)

NCT ID: NCT03058835

Last Updated: 2026-08-13

Results Overview

Assessment of participants' attitudes toward pre-exposure prophylaxis using questionnaires

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

162 participants

Primary outcome timeframe

24 weeks

Results posted on

2026-08-13

Participant Flow

A total of 162 individuals were screened across four academic medical centers. Recruitment targeted individuals at risk for HIV through clinics, community outreach, and social media between the dates of September 2016 and April 2019.

After providing informed consent, 11 participants did not proceed to assignment/initiation of study participation because they did not meet the eligibility criteria identified during screening procedures.

Participant milestones

Participant milestones
Measure	PrEP With Truvada All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP tenofovir disoproxil and emtricitabine: Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.
Overall Study STARTED	151
Overall Study COMPLETED	121
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	PrEP With Truvada All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP tenofovir disoproxil and emtricitabine: Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.
Overall Study Lost to Follow-up	27
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Questionnaires were completed at Screening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PrEP With Truvada n=162 Participants All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP tenofovir disoproxil and emtricitabine: Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.
Age, Customized 18-24 years	9 Participants n=155 Participants • Questionnaires were completed at Screening
Age, Customized 25-44 years	73 Participants n=155 Participants • Questionnaires were completed at Screening
Age, Customized 45 years and older	73 Participants n=155 Participants • Questionnaires were completed at Screening
Age, Customized Unknown / No response	7 Participants n=162 Participants • Questionnaires were completed at Screening
Sex: Female, Male Female	162 Participants n=162 Participants
Sex: Female, Male Male	0 Participants n=162 Participants
Race/Ethnicity, Customized Black	109 Participants n=162 Participants • Percentages may not sum to 100% due to missing responses.
Race/Ethnicity, Customized White	44 Participants n=162 Participants • Percentages may not sum to 100% due to missing responses.
Race/Ethnicity, Customized Hispanic	3 Participants n=162 Participants • Percentages may not sum to 100% due to missing responses.
Race/Ethnicity, Customized Other	6 Participants n=162 Participants • Percentages may not sum to 100% due to missing responses.
Region of Enrollment United States · Atlanta	42 Participants n=162 Participants • The overall screening denominator (N = 162) reflects post-screening data reconciliation, including removal of duplicate records and participants screened in error prior to assignment of a screening outcome. Site-level screening counts reflect local screening activity, whereas the overall total represents the finalized population included in Results reporting.
Region of Enrollment United States · Chicago	52 Participants n=162 Participants • The overall screening denominator (N = 162) reflects post-screening data reconciliation, including removal of duplicate records and participants screened in error prior to assignment of a screening outcome. Site-level screening counts reflect local screening activity, whereas the overall total represents the finalized population included in Results reporting.
Region of Enrollment United States · Newark	37 Participants n=162 Participants • The overall screening denominator (N = 162) reflects post-screening data reconciliation, including removal of duplicate records and participants screened in error prior to assignment of a screening outcome. Site-level screening counts reflect local screening activity, whereas the overall total represents the finalized population included in Results reporting.
HIV High-Risk Eligibility Criteria (Counts) IDU/Treatment program participation	96 Participants n=162 Participants
HIV High-Risk Eligibility Criteria (Counts) Engagement in transactional sex	90 Participants n=162 Participants
Region of Enrollment United States · West Virginia	31 Participants n=162 Participants • The overall screening denominator (N = 162) reflects post-screening data reconciliation, including removal of duplicate records and participants screened in error prior to assignment of a screening outcome. Site-level screening counts reflect local screening activity, whereas the overall total represents the finalized population included in Results reporting.
Education High school / GED	50 Participants n=162 Participants
Education Some college / tech school	42 Participants n=162 Participants
Education College / technical school grad	27 Participants n=162 Participants
Education Unknown / No response	43 Participants n=162 Participants
Baseline HIV Risk Factors and Sexual Behavior History of STI :	94 Participants n=162 Participants • Baseline questionnaire data were collected at screening among consented participants (N=162). "Not reported/Unknown" categories account for missing responses, so that totals sum to N=162.
Baseline HIV Risk Factors and Sexual Behavior HIV-positive sexual partner :	26 Participants n=162 Participants • Baseline questionnaire data were collected at screening among consented participants (N=162). "Not reported/Unknown" categories account for missing responses, so that totals sum to N=162.
Baseline HIV Risk Factors and Sexual Behavior Always discuss HIV with partners :	66 Participants n=162 Participants • Baseline questionnaire data were collected at screening among consented participants (N=162). "Not reported/Unknown" categories account for missing responses, so that totals sum to N=162.
Baseline HIV Risk Factors and Sexual Behavior Never discuss HIV with partners :	64 Participants n=162 Participants • Baseline questionnaire data were collected at screening among consented participants (N=162). "Not reported/Unknown" categories account for missing responses, so that totals sum to N=162.
Baseline HIV Risk Factors and Sexual Behavior Worry about getting HIV "all the time" :	42 Participants n=162 Participants • Baseline questionnaire data were collected at screening among consented participants (N=162). "Not reported/Unknown" categories account for missing responses, so that totals sum to N=162.
Baseline HIV Risk Factors and Sexual Behavior Worry about getting HIV "often" :	41 Participants n=162 Participants • Baseline questionnaire data were collected at screening among consented participants (N=162). "Not reported/Unknown" categories account for missing responses, so that totals sum to N=162.
Baseline HIV Risk Factors and Sexual Behavior Recent HIV test (within 6 months) :	108 Participants n=162 Participants • Baseline questionnaire data were collected at screening among consented participants (N=162). "Not reported/Unknown" categories account for missing responses, so that totals sum to N=162.
Baseline HIV Risk Factors and Sexual Behavior Multiple sexual partners (11+ lifetime) :	93 Participants n=162 Participants • Baseline questionnaire data were collected at screening among consented participants (N=162). "Not reported/Unknown" categories account for missing responses, so that totals sum to N=162.
Baseline HIV Risk Factors and Sexual Behavior Multiple recent partners (3+ in 6 months) :	69 Participants n=162 Participants • Baseline questionnaire data were collected at screening among consented participants (N=162). "Not reported/Unknown" categories account for missing responses, so that totals sum to N=162.
Sexual Risk Behaviors Use birth control	75 Participants n=162 Participants
Sexual Risk Behaviors Condom use (male/female condoms)	63 Participants n=162 Participants
Sexual Risk Behaviors Frequent sexual activity (3+ times/week)	109 Participants n=162 Participants
Sexual Risk Behaviors Age at first intercourse <16 years	111 Participants n=162 Participants
Employment Status (screening) Currently Employed	162 Participants n=162 Participants
Employment Status (screening) Full-time homemaker	8 Participants n=162 Participants
Employment Status (screening) Full-time job	21 Participants n=162 Participants
Employment Status (screening) Full-time student	3 Participants n=162 Participants
Employment Status (screening) Part-time job	16 Participants n=162 Participants
Employment Status (screening) Unemployed	114 Participants n=162 Participants
HIV High-Risk Eligibility Criteria (Counts) HIV High-Risk Eligibility Criteria (Counts)	162 Participants n=162 Participants
HIV High-Risk Eligibility Criteria (Counts) Sex with an HIV-infected partner	121 Participants n=162 Participants
HIV High-Risk Eligibility Criteria (Counts) Infrequent condom use	87 Participants n=162 Participants
HIV High-Risk Eligibility Criteria (Counts) History of STI evaluation (prior 6 months)	63 Participants n=162 Participants
HIV High-Risk Eligibility Criteria (Counts) Unprotected sex with 1+ men of unknown status	26 Participants n=162 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Population: Twenty-five participants contributed a total of 49 analyzed dried blood spot samples: 24 samples collected at Week 12 and 25 samples collected at Week 24. Each participant contributed no more than one analyzed sample at each time point. One Week 12 sample was rejected and was not analyzed. Accordingly, the Number Analyzed is 24 samples for each Week 12 row and 25 samples for each Week 24 row.

Dried blood spot tenofovir-diphosphate levels were summarized using prespecified adherence threshold categories at week 12 and week 24.

Outcome measures

Outcome measures
Measure	PrEP With Truvada n=49 Samples All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP tenofovir disoproxil and emtricitabine: Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots Week 12: Moderate adherence (350-699 fmol/punch)	5 Samples
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots Week 12: Low adherence (<350 fmol/punch)	3 Samples
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots Week 12: High adherence (≥700 fmol/punch)	5 Samples
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots Week 12: Below quantification limit (BLQ)	11 Samples
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots Week 24: High adherence (≥700 fmol/punch)	5 Samples
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots Week 24: Moderate adherence (350-699 fmol/punch)	1 Samples
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots Week 24: Low adherence (<350 fmol/punch)	7 Samples
Evaluate Adherence to Truvada PrEP at Week 12 and Week 24 Using Dried Blood Spots Week 24: Below quantification limit (BLQ)	12 Samples

PRIMARY outcome

Timeframe: 24 weeks

Population: Questionnaire items related to PrEP awareness and interest were assessed at the Week 24 visit. Results are reported as counts and percentages of participants with each response at Week 24.

Assessment of participants' attitudes toward pre-exposure prophylaxis using questionnaires

Outcome measures

Outcome measures
Measure	PrEP With Truvada n=162 Participants All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP tenofovir disoproxil and emtricitabine: Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.
PrEP Awareness and Interest Questionnaire Responses at Week 24 Heard of PrEP	67 Participants
PrEP Awareness and Interest Questionnaire Responses at Week 24 Want to learn about PrEP	154 Participants
PrEP Awareness and Interest Questionnaire Responses at Week 24 Would to take PrEP	157 Participants
PrEP Awareness and Interest Questionnaire Responses at Week 24 Would pay for PrEP	85 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Evaluation of feasibility using logistic regression comparing the proportion of participants with tenofovir plasma levels \>0.3

Outcome measures

Outcome measures
Measure	PrEP With Truvada n=121 Participants All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP tenofovir disoproxil and emtricitabine: Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.
Feasibility of Obtaining Truvada Via the Gilead Access Program Participants with detectable levels >0.3 pmol/punch	9 Participants
Feasibility of Obtaining Truvada Via the Gilead Access Program Participants with no detectable levels >0.3 pmol/punch	112 Participants

Adverse Events

PrEP With Truvada

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PrEP With Truvada n=162 participants at risk All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP tenofovir disoproxil and emtricitabine: Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.
Gastrointestinal disorders Nausea	6.2% 10/162 • From enrollment through study completion (24 weeks) Adverse events were systematically collected at each study visit through participant interviews and clinical assessments. Non-serious adverse events occurring in ≥5% of participants are reported. Events were coded using standard medical terminology and assessed for relationship to study drug.

Additional Information

Shobha Swaminathan, MD

Rutgers New Jersey Medical School

Phone: 973-972-1057

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place