HIV Infections
Conditions
Keywords
Microbicide, HIV Seronegativity
Brief summary
A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved, anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the adherence and acceptability to and blood levels of three daily regimens of tenofovir in both oral and gel form.
Detailed description
It is necessary to monitor both the adherence and blood levels of microbicides in order to gauge its efficacy in a study population. Utilizing an experimental microbicide (tenofovir gel) and an anti-HIV drug (TDF), this study will measure the adherence and acceptability to and blood levels of the two interventions in three separate regimens given to HIV-uninfected women. The expected duration of participation for each participant is 21 weeks. Study participants will be randomly assigned into one of six study groups, each with a different regimen sequence. Each sequence will consist of three study periods and three wash-out periods. Each study period lasts 6 weeks, followed by a 1 week wash-out period. The regimen assigned for a given study period will include either oral TDF, tenofovir vaginal gel, or both. All participants will be prescribed all three regimens in the order designated by their randomized assignment. Study visits will occur at Weeks 1, 3, 6, 7, 10, 13, 14, 17, 20, and 21. Medical history, a physical exam, behavioral assessment, and urine, blood, pelvic sample collection, and counseling will occur at all visits. At some study sites rectal swabs may be performed. Counseling will include information regarding contraception, protocol adherence, HIV, HIV/Sexually Transmitted Infection risk reduction, and male condom use. Pharmacokinetic (PK) studies, to be determined by the study site, will occur during all three study periods. These studies may involve additional procedures.
Interventions
DRUGTenofovir disoproxil fumarate
300 mg tablet daily
DRUGTenofovir gel
1 gm/100 ml of 1% gel vaginally daily
Sponsors
Microbicide Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* General good health * HIV-uninfected * Normal menstrual cycle. More information can be found in the protocol. * Creatinine clearance greater than 70 ml/min * Sexually active. More information can be found in the protocol. * Normal Pap smear result within 12 months prior to study entry * Agrees to not participate in other investigational studies * Willing to use effective forms of contraception. More information can be found in the protocol.
Exclusion criteria
* Adverse reaction to either of the study products * Adverse reaction to latex * Currently sexually active with a partner with history of adverse reaction to latex * More than three sexual partners in the month prior to screening * Pathologic bone fracture not related to trauma * Last pregnancy outcome within 90 days or less prior to enrollment * Gynecologic or genital procedure within 90 days of study entry * Enrollment in other investigational study within 30 days of study entry * Nontherapeutic injection drug use within 12 months of screening * Any social or medical condition that, in the opinion of the investigator, would interfere with the study * Abnormal laboratory values * Grade 2 or higher genital lesions, erythema, and/or edema or has any other abnormal physical or pelvic exam finding that, in the opinion of the investigator, would interfere with the study * Kidney, reproductive, or urinary tract infection requiring treatment. More information on this criterion can be found in the protocol. * Pregnant, breastfeeding, or intend to become pregnant * Unwilling to comply with study participation requirements, including attendance at all scheduled study visits * Per participant report, use of the following at enrollment, and/or anticipated use during the period of study participation - use of a diaphragm, vaginal ring, and/or spermicide for contraception, acyclovir or valacyclovir, post-exposure prophylaxis for HIV exposure, TDF/emtricitabine, non-study vaginal products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Adherence to Each Regimen | Measured through Week 21 | Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent. |
| Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future | Measured through Week 21 | — |
| Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) | Measured through Week 21 | PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Product Missed | Measured through Week 21 | This represents the longest number of days in a row during the past 3 weeks that a participant missed using the study product. |
| Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses | Measured through Week 21 | — |
| Frequency of Sexual Activity | Measured through Week 21 | This represents the rate during the past 3 weeks at which participants engaged in vaginal sex. |
| Frequency of Male Condom Use | Measured through Week 21 | — |
| Tablet Usage Before Sex | Measured through Week 21 | These summaries represent counts and percentages of participants using tablet before last instance of vaginal sex. |
| Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet. | Measured through Week 21 | Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used before the encounter). |
| Tablet Usage After Sex | Measured through Week 21 | These summaries represent counts and percentages of participants using tablet after last instance of vaginal sex. |
| Length of Time Vaginal Sexual Intercourse Took Place After Using Gel. | Measured through Week 21 | Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used before the encounter). |
| Gel Usage After Sex | Measured through Week 21 | These summaries represent counts and percentages of participants using gel after last instance of vaginal sex. |
| Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel. | Measured through Week 21 | Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used after the encounter). |
| Reported Sharing of Product | Measured through Week 21 | Number and percentage of participants who had a product sharing event during the 6-week product use period, where a sharing event includes 1) being asked for the study product, or 2) selling, trading, or giving away study product, or 3) having someone take the study product from the participant. |
| Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol | Measured through Week 21 | — |
| Gel Usage Before Sex | Measured through Week 21 | These summaries represent counts and percentages of participants using gel before last instance of vaginal sex. |
| Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet. | Measured through Week 21 | Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used after the encounter). |
| Frequency of Product Use | Measured through Week 21 | This number represents how often participant used study product during the preceding 3 weeks and is measured twice during each 6 week product period. |
Countries
South Africa, Uganda, United States
Participant flow
Recruitment details
Participants in this study were selected from a total of 7 multinational clinical research sites, with first enrollment taking place on 4 March 2009 and last on 3 February 2010.
Participants by arm
| Arm | Count |
|---|---|
| O, V, OV Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily | 24 |
| V, O, OV Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily | 24 |
| OV, O, V Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily | 24 |
| OV, V, O Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily | 24 |
| O, OV, V Oral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily | 24 |
| V, OV, O Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20
Tenofovir disoproxil fumarate: 300 mg tablet daily
Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily | 24 |
| Total | 144 |
Baseline characteristics
| Characteristic | Total | V, OV, O | O, OV, V | OV, V, O | OV, O, V | O, V, OV | V, O, OV |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 30.8 years STANDARD_DEVIATION 7.1 | 31.3 years STANDARD_DEVIATION 8.2 | 31.1 years STANDARD_DEVIATION 7.5 | 31.3 years STANDARD_DEVIATION 6.4 | 29.8 years STANDARD_DEVIATION 6.5 | 32.3 years STANDARD_DEVIATION 7.6 | 29.1 years STANDARD_DEVIATION 6.3 |
| Are you currently married? No | 87 Participants | 12 Participants | 15 Participants | 14 Participants | 16 Participants | 15 Participants | 15 Participants |
| Are you currently married? Yes | 57 Participants | 12 Participants | 9 Participants | 10 Participants | 8 Participants | 9 Participants | 9 Participants |
| Do you currently have a male sex partner? No | 59 Participants | 12 Participants | 10 Participants | 11 Participants | 8 Participants | 9 Participants | 9 Participants |
| Do you currently have a male sex partner? Yes | 85 Participants | 12 Participants | 14 Participants | 13 Participants | 16 Participants | 15 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants | 11 Participants | 13 Participants | 10 Participants | 12 Participants | 11 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 71 Participants | 12 Participants | 11 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 5 Participants | 6 Participants | 4 Participants | 9 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 7 Participants | 5 Participants | 6 Participants | 3 Participants | 5 Participants | 6 Participants |
| Region of Enrollment South Africa | 48 participants | 8 participants | 8 participants | 8 participants | 8 participants | 8 participants | 8 participants |
| Region of Enrollment Uganda | 24 participants | 4 participants | 4 participants | 4 participants | 4 participants | 4 participants | 4 participants |
| Region of Enrollment United States | 72 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants |
| Sex: Female, Male Female | 144 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| What is your highest education level? Attended College or University | 62 Participants | 11 Participants | 9 Participants | 11 Participants | 11 Participants | 8 Participants | 12 Participants |
| What is your highest education level? No Schooling | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| What is your highest education level? Primary School, Complete | 7 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| What is your highest education level? Primary School, Not Complete | 8 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants |
| What is your highest education level? Secondary School, Complete | 29 Participants | 2 Participants | 6 Participants | 4 Participants | 6 Participants | 8 Participants | 3 Participants |
| What is your highest education level? Secondary School, Not Complete | 37 Participants | 8 Participants | 7 Participants | 6 Participants | 4 Participants | 7 Participants | 5 Participants |
| What is your household(s) average monthly income? | 495.40 US Dollars | 306.75 US Dollars | 368.10 US Dollars | 490.80 US Dollars | 417.18 US Dollars | 495.40 US Dollars | 773.01 US Dollars |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 86 / 168 | 89 / 168 | 64 / 168 |
| serious Total, serious adverse events | 1 / 168 | 3 / 168 | 1 / 168 |
Outcome results
Primary
Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future
Time frame: Measured through Week 21
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future | Likely | 115 Participants |
| Vaginal and Oral Tenofovir | Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future | Unlikely | 26 Participants |
| Oral Tenofovir | Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future | Likely | 130 Participants |
| Oral Tenofovir | Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future | Unlikely | 9 Participants |
| Vaginal Tenofovir | Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future | Likely | 117 Participants |
| Vaginal Tenofovir | Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future | Unlikely | 25 Participants |
Primary
Self-reported Adherence to Each Regimen
Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent.
Time frame: Measured through Week 21
Population: For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of expected doses if she were fully adherent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Self-reported Adherence to Each Regimen | 94 percentage of expected doses | Standard Deviation 10.8 |
| Oral Tenofovir | Self-reported Adherence to Each Regimen | 93.8 percentage of expected doses | Standard Deviation 10.2 |
| Vaginal Tenofovir | Self-reported Adherence to Each Regimen | 93.9 percentage of expected doses | Standard Deviation 10.1 |
Primary
Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)
PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage.
Time frame: Measured through Week 21
Population: Serum TFV and Tissue TFV measures do not include participants from South Africa clinical sites.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) | Tissue TFV | 104 ng/mL, ng/mg, ng/mL |
| Vaginal and Oral Tenofovir | Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) | Serum TFV Cmax | 337 ng/mL, ng/mg, ng/mL |
| Vaginal and Oral Tenofovir | Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) | Cervicovaginal lavage | 1600000 ng/mL, ng/mg, ng/mL |
| Oral Tenofovir | Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) | Tissue TFV | 0.15 ng/mL, ng/mg, ng/mL |
| Oral Tenofovir | Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) | Serum TFV Cmax | 332 ng/mL, ng/mg, ng/mL |
| Oral Tenofovir | Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) | Cervicovaginal lavage | 5380 ng/mL, ng/mg, ng/mL |
| Vaginal Tenofovir | Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) | Serum TFV Cmax | 3.9 ng/mL, ng/mg, ng/mL |
| Vaginal Tenofovir | Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) | Cervicovaginal lavage | 3100000 ng/mL, ng/mg, ng/mL |
| Vaginal Tenofovir | Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) | Tissue TFV | 113 ng/mL, ng/mg, ng/mL |
Secondary
Frequency of Male Condom Use
Time frame: Measured through Week 21
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Frequency of Male Condom Use | Most of the time | 26 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Male Condom Use | Sometimes | 22 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Male Condom Use | Never | 71 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Male Condom Use | Rarely | 19 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Male Condom Use | Always | 128 3-week periods |
| Oral Tenofovir | Frequency of Male Condom Use | Sometimes | 24 3-week periods |
| Oral Tenofovir | Frequency of Male Condom Use | Never | 80 3-week periods |
| Oral Tenofovir | Frequency of Male Condom Use | Rarely | 21 3-week periods |
| Oral Tenofovir | Frequency of Male Condom Use | Most of the time | 27 3-week periods |
| Oral Tenofovir | Frequency of Male Condom Use | Always | 120 3-week periods |
| Vaginal Tenofovir | Frequency of Male Condom Use | Always | 131 3-week periods |
| Vaginal Tenofovir | Frequency of Male Condom Use | Most of the time | 28 3-week periods |
| Vaginal Tenofovir | Frequency of Male Condom Use | Never | 69 3-week periods |
| Vaginal Tenofovir | Frequency of Male Condom Use | Sometimes | 15 3-week periods |
| Vaginal Tenofovir | Frequency of Male Condom Use | Rarely | 28 3-week periods |
Secondary
Frequency of Product Use
This number represents how often participant used study product during the preceding 3 weeks and is measured twice during each 6 week product period.
Time frame: Measured through Week 21
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Frequency of Product Use | Once/day | 227 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Product Use | Less than once/week | 1 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Product Use | 1-3 times/week | 7 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Product Use | 4-6 times/week | 48 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Product Use | Never | 0 3-week periods |
| Oral Tenofovir | Frequency of Product Use | 4-6 times/week | 59 3-week periods |
| Oral Tenofovir | Frequency of Product Use | 1-3 times/week | 5 3-week periods |
| Oral Tenofovir | Frequency of Product Use | Never | 1 3-week periods |
| Oral Tenofovir | Frequency of Product Use | Once/day | 216 3-week periods |
| Oral Tenofovir | Frequency of Product Use | Less than once/week | 1 3-week periods |
| Vaginal Tenofovir | Frequency of Product Use | Once/day | 232 3-week periods |
| Vaginal Tenofovir | Frequency of Product Use | Less than once/week | 0 3-week periods |
| Vaginal Tenofovir | Frequency of Product Use | Never | 3 3-week periods |
| Vaginal Tenofovir | Frequency of Product Use | 4-6 times/week | 41 3-week periods |
| Vaginal Tenofovir | Frequency of Product Use | 1-3 times/week | 9 3-week periods |
Secondary
Frequency of Sexual Activity
This represents the rate during the past 3 weeks at which participants engaged in vaginal sex.
Time frame: Measured through Week 21
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Frequency of Sexual Activity | Once/day | 11 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Sexual Activity | 4-6 times/week | 58 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Sexual Activity | Less than once/week | 18 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Sexual Activity | 1-3 times/week | 170 3-week periods |
| Vaginal and Oral Tenofovir | Frequency of Sexual Activity | More than once/day | 7 3-week periods |
| Oral Tenofovir | Frequency of Sexual Activity | 4-6 times/week | 55 3-week periods |
| Oral Tenofovir | Frequency of Sexual Activity | Less than once/week | 14 3-week periods |
| Oral Tenofovir | Frequency of Sexual Activity | 1-3 times/week | 179 3-week periods |
| Oral Tenofovir | Frequency of Sexual Activity | Once/day | 18 3-week periods |
| Oral Tenofovir | Frequency of Sexual Activity | More than once/day | 6 3-week periods |
| Vaginal Tenofovir | Frequency of Sexual Activity | More than once/day | 12 3-week periods |
| Vaginal Tenofovir | Frequency of Sexual Activity | Once/day | 17 3-week periods |
| Vaginal Tenofovir | Frequency of Sexual Activity | Less than once/week | 10 3-week periods |
| Vaginal Tenofovir | Frequency of Sexual Activity | 4-6 times/week | 48 3-week periods |
| Vaginal Tenofovir | Frequency of Sexual Activity | 1-3 times/week | 184 3-week periods |
Secondary
Gel Usage After Sex
These summaries represent counts and percentages of participants using gel after last instance of vaginal sex.
Time frame: Measured through Week 21
Population: Last instance of vaginal intercourse on the same day as gel use
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Gel Usage After Sex | No | 142 Sexual Encounters |
| Vaginal and Oral Tenofovir | Gel Usage After Sex | Yes | 112 Sexual Encounters |
| Oral Tenofovir | Gel Usage After Sex | Yes | 114 Sexual Encounters |
| Oral Tenofovir | Gel Usage After Sex | No | 147 Sexual Encounters |
Secondary
Gel Usage Before Sex
These summaries represent counts and percentages of participants using gel before last instance of vaginal sex.
Time frame: Measured through Week 21
Population: Last instance of vaginal intercourse on the same day as gel use
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Gel Usage Before Sex | No | 111 Sexual Encounters |
| Vaginal and Oral Tenofovir | Gel Usage Before Sex | Yes | 142 Sexual Encounters |
| Oral Tenofovir | Gel Usage Before Sex | Yes | 151 Sexual Encounters |
| Oral Tenofovir | Gel Usage Before Sex | No | 111 Sexual Encounters |
Secondary
Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol
Time frame: Measured through Week 21
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaginal and Oral Tenofovir | Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol | 5 Participants |
| Oral Tenofovir | Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol | 5 Participants |
| Vaginal Tenofovir | Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol | 3 Participants |
Secondary
Length of Time Vaginal Sexual Intercourse Took Place After Using Gel.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used before the encounter).
Time frame: Measured through Week 21
Population: Last instances of vaginal sexual intercourse wherein gel was used before the encounters.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vaginal and Oral Tenofovir | Length of Time Vaginal Sexual Intercourse Took Place After Using Gel. | 60.0 minutes |
| Oral Tenofovir | Length of Time Vaginal Sexual Intercourse Took Place After Using Gel. | 60.0 minutes |
Secondary
Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used before the encounter).
Time frame: Measured through Week 21
Population: Last instances of vaginal sexual intercourse wherein tablets were used before the encounters. Timing data was not provided for four sexual encounters.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vaginal and Oral Tenofovir | Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet. | 60.0 minutes |
| Oral Tenofovir | Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet. | 90.0 minutes |
Secondary
Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used after the encounter).
Time frame: Measured through Week 21
Population: Last instances of vaginal sexual intercourse wherein gel was used after the encounters.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vaginal and Oral Tenofovir | Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel. | 75.0 minutes |
| Oral Tenofovir | Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel. | 120.0 minutes |
Secondary
Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used after the encounter).
Time frame: Measured through Week 21
Population: Last instances of vaginal sexual intercourse wherein tablets were used after the encounters. Timing data was not provided for two sexual encounters.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vaginal and Oral Tenofovir | Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet. | 90.0 minutes |
| Oral Tenofovir | Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet. | 120.0 minutes |
Secondary
Number of Days Product Missed
This represents the longest number of days in a row during the past 3 weeks that a participant missed using the study product.
Time frame: Measured through Week 21
Population: This outcome is based on evaluable participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Number of Days Product Missed | 0.9 days | Standard Deviation 1.9 |
| Oral Tenofovir | Number of Days Product Missed | 0.9 days | Standard Deviation 2.3 |
| Vaginal Tenofovir | Number of Days Product Missed | 0.9 days | Standard Deviation 2.4 |
Secondary
Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses
Time frame: Measured through Week 21
Population: This outcome is based on evaluable participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses | Yes | 114 Participants |
| Vaginal and Oral Tenofovir | Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses | No | 30 Participants |
| Oral Tenofovir | Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses | Yes | 114 Participants |
| Oral Tenofovir | Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses | No | 30 Participants |
| Vaginal Tenofovir | Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses | Yes | 122 Participants |
| Vaginal Tenofovir | Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses | No | 22 Participants |
Secondary
Reported Sharing of Product
Number and percentage of participants who had a product sharing event during the 6-week product use period, where a sharing event includes 1) being asked for the study product, or 2) selling, trading, or giving away study product, or 3) having someone take the study product from the participant.
Time frame: Measured through Week 21
Population: Participants who completed a product sharing assessment at the end of the 6-week product use period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaginal and Oral Tenofovir | Reported Sharing of Product | 2 Participants |
| Oral Tenofovir | Reported Sharing of Product | 0 Participants |
| Vaginal Tenofovir | Reported Sharing of Product | 3 Participants |
Secondary
Tablet Usage After Sex
These summaries represent counts and percentages of participants using tablet after last instance of vaginal sex.
Time frame: Measured through Week 21
Population: Last instance of vaginal intercourse on the same day as tablet use
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Tablet Usage After Sex | Yes | 105 Sexual Encounters |
| Vaginal and Oral Tenofovir | Tablet Usage After Sex | No | 150 Sexual Encounters |
| Oral Tenofovir | Tablet Usage After Sex | Yes | 83 Sexual Encounters |
| Oral Tenofovir | Tablet Usage After Sex | No | 183 Sexual Encounters |
Secondary
Tablet Usage Before Sex
These summaries represent counts and percentages of participants using tablet before last instance of vaginal sex.
Time frame: Measured through Week 21
Population: Last instance of vaginal intercourse on the same day as tablet use
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Vaginal and Oral Tenofovir | Tablet Usage Before Sex | Yes | 150 Sexual encounters |
| Vaginal and Oral Tenofovir | Tablet Usage Before Sex | No | 104 Sexual encounters |
| Oral Tenofovir | Tablet Usage Before Sex | Yes | 186 Sexual encounters |
| Oral Tenofovir | Tablet Usage Before Sex | No | 80 Sexual encounters |