HIV InfectionsPhase 2NCT03593655
Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population
A Phase 2 study testing Dapivirine vaginal ring and FTC/TDF in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females. Read more about this study
- Who is it for?
- Ages 16 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dapivirine vaginal ring and FTC/TDF
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 14 Jan 2019to 9 Sep 2021
- 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 16 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16 through 21 years (inclusive) at Enrollment, verified per site standard operating procedures (SOPs).
- Able and willing to provide informed consent, and if under the legal age of consent be able to provide informed assent and obtain parental or guardian permission/consent, to be screened for and to enroll in MTN-034 (as specified in site SOP).
- Able and willing to provide adequate locator information, as defined in site SOPs.
- Able and willing to comply with all study procedural requirements.
- Per participant report at Screening, post-menarche.
- HIV-uninfected based on testing performed at Screening and Enrollment (per protocol algorithms found in the study protocol).
Show all 16Show fewer
- Per participant report at Screening, history of at least one episode of sexual intercourse in participant's lifetime.
- Negative pregnancy test at Screening and Enrollment.
- Per participant report, use of an effective method of contraception for at least two months prior to Enrollment, and intending to continue use of an effective method for the duration of study participation; effective methods include:
- hormonal methods (except contraceptive ring).
- intrauterine device (IUD).
- Note: Participant must be on the same contraception method for at least the two months prior to Enrollment.
- Per participant report at Screening, willing to abstain from inserting anything into the vagina for 72 hours prior to each study visit, including receptive intercourse.
- Note: In the event the VR has been expelled and requires reinsertion, repositioning the VR is permitted.
- Note: Participant use of tampons is permitted at any time during the study.
- At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation, unless approved by the Protocol Safety Review Team (PSRT).
Who cannot join
- Per participant report at Screening and Enrollment, intends to do any of the following during the study participation period:
- become pregnant.
- access and/or use oral PrEP outside the context of study participation.
- relocate away from the study site.
- travel away from the study site for a time period that would interfere with product resupply and study participation.
- At Screening or Enrollment, has a positive HIV test.
Show all 27Show fewer
- Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), sexually transmitted infection (STI) or reproductive tract infection (RTI) requiring treatment per World Health Organization (WHO) guidelines at Screening or Enrollment.
- Note: Otherwise eligible participants diagnosed during screening with a UTI, PID or STI/RTI requiring treatment per WHO guidelines - other than asymptomatic bacterial vaginosis (BV) and asymptomatic candidiasis - are offered treatment consistent with WHO recommendations. If treatment is completed and symptoms have resolved within 70 days of obtaining informed assent/consent for screening, the participant may be enrolled. Genital warts requiring treatment also must be treated prior to enrollment. Genital warts requiring therapy are defined as those that cause undue burden or discomfort to the participant, including bulky size, unacceptable appearance, or physical discomfort.
- At Enrollment, has a clinically apparent Grade 2 or higher pelvic exam finding.
- Note: Cervical friability bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the Investigator of Record (IoR)/designee is considered expected non-menstrual bleeding and is not exclusionary.
- Note: Otherwise eligible participants with exclusionary pelvic exam findings may be enrolled/randomized after the findings have improved to a non-exclusionary severity grading or resolved. If improvement to a non-exclusionary grade or resolution is documented within 70 days of providing informed assent/consent for screening, the participant may be enrolled.
- Participant report and/or clinical evidence of any of the following:
- Known adverse reaction to any of the study products (ever).
- Known adverse reaction to latex and polyurethane (ever).
- Symptoms suggestive of acute HIV infection at Screening or Enrollment.
- Non-therapeutic injection drug use in the 12 months prior to Enrollment.
- Use of HIV PEP and/or PrEP within the 3 months prior to Enrollment.
- Currently breastfeeding.
- Last pregnancy outcome within 8 weeks or less of Enrollment.
- Participation in any other research study involving drugs, medical devices, vaginal products or vaccines within 60 days of Enrollment.
- At Enrollment, as determined by the IoR/designee, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease.
- Has any of the following laboratory abnormalities at Screening Visit:
- Positive for hepatitis B surface antigen (HBsAG).
- Hemoglobin Grade 2 or higher.
- Calculated creatinine clearance less than 60 mL/min by the Schwartz Equation.
- Note: Otherwise eligible participants with an exclusionary test may be re-tested during the screening process; re-testing procedure details can be found in the MTN-034 Study Specific Procedures (SSP) Manual. If improvement to a non-exclusionary grade or resolution is documented within 70 days of providing informed assent/consent for screening, the participant may be enrolled.
- Has any other condition that, in the opinion of the IoR/designee, would preclude informed assent/consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
South Africa2 sites
Emavundleni CRS
Cape Town, Western Cape, 7750
Wits Reproductive Health and HIV Institute CRS (WRHI CRS)
Johannesburg, Gauteng, 2038
About this study
Official title: A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population
The purpose of this study is to evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females.
Read the detailed description
This study will evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females.
The study will enroll healthy, HIV-uninfected adolescent and young adult females between 16 and 21 years of age. Participants will be randomized to one of two sequences of one VR containing 25 mg of dapivirine to be inserted monthly for 24 weeks and one 200 mg FTC/300 mg TDF oral tablet taken daily for 24 weeks. After completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. Participants will be able to choose either or neither study product during the third product use period. The study includes approximately 76 weeks of follow-up per participant.
Participants will attend monthly study visits, which may include behavioral assessments/counseling; physical and pelvic examinations; and blood, urine, and pelvic sample collection.
- Conditions
- HIV Infections
- Being tested
- Dapivirine vaginal ring, FTC/TDF
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapivirine vaginal ringDevice
Vaginal ring containing 25 mg of dapivirine
FTC/TDFDrug
Also called Emtricitabine/Tenofovir Disoproxil Fumarate; Truvada
Tablet containing 200 mg FTC/300 mg TDF
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Dapivirine vaginal ring + FTC/TDF | Experimental | Participants will receive one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks. Receives: Device: Dapivirine vaginal ring; Drug: FTC/TDF |
| Sequence B: FTC/TDF + Dapivirine vaginal ring | Experimental | Participants will receive one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks. Receives: Device: Dapivirine vaginal ring; Drug: FTC/TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 2 or Higher Adverse Events (AEs)
During participants' first year on study (i.e., during first and second product use periods) participants were randomized to use either the dapivirine vaginal ring for 6 months followed by FTC/TDF for 6 months or vice versa. All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. AEs that were graded as at least Grade 2 (i.e., "moderate" or higher) were classified into the two periods based on reported date of AE onset, with AEs occurring between the participant's randomization date and the date 30 days after their Week 24 visit classified into Period 1, and AEs occurring between their Week 24 visit and the date 30 days after their Week 48 visit classified into Period 2. AEs occurring within 30 days of the Week 24 visit were counted in both periods.
This is the number of participant-periods with at least one grade 2 or higher AE by product (combining the two product use periods).
Measured: Study periods 1 and 2
Number of Participant-Visits With No Product Use
During the study period where participants were randomized to use FTC/TDF they were assessed for FTC/TDF adherence by dried blood spot (DBS) at monthly visits. Results that were below the lower limit of detection (< 16.6 fmol/punch) were classified as no use of FTC/TDF during the preceding month, and detectable results (>= 16.6 fmol/punch) classified as at least some FTC/TDF use.
During the study period where participants were randomized to use the dapivirine vaginal ring (VR) they were assessed for ring adherence by residual drug levels in returned VRs. Results that were less than or equal to a rate of 0.9mg dapivirine released per month were classified as no use of the VR during that month, and results greater than 0.9mg dapivirine release per month classified as at least some VR use.
Measured: Study periods 1 and 2
Secondary outcomes (4)
Number of Participant-Visits Reporting Acceptability of Study Product
During the study period where participants were randomized to use FTC/TDF they were asked to rate how much they liked using the tablets for HIV prevention (3 and 6 months after initiating the product).
During the study period where participants were randomized to use the dapivirine vaginal ring they were asked to rate how much they liked using the ring for HIV prevention (3 and 6 months after initiating the product).
Measured: Study periods 1 and 2
Number of Participant-Visits With No Product Use
During the study period where participants chose which product they used (i.e., Weeks 49-72) they were assessed for FTC/TDF adherence by dried blood spot (DBS) and/or dapivirine vaginal ring adherence by residual drug levels in returned VRs at monthly visits, depending on which product they chose. Results that were below the lower limit of detection (< 16.6 fmol/punch) were classified as no use of FTC/TDF during the preceding month, and detectable results (>= 16.6 fmol/punch) classified as at least some FTC/TDF use. Results that were less than or equal to a rate of 0.9mg dapivirine released per month were classified as no use of the VR during that month, and results greater than 0.9mg dapivirine release per month classified as at least some VR use.
Measured: Study period 3 (Weeks 49-72)
Number of Participants Selecting Each Study Product
During the third study product use period (i.e., Weeks 49-72) participants chose whether to use the dapivirine VR, FTC/TDF oral tablets, or neither product, and could change their decision throughout the 6 month period. Participants were categorized into one of four categories based on their selection pattern: always chose dapivirine VR, always chose FTC/TDF oral tablets, switched at least once (including switching to or from no product), and never chose either product.
Measured: Study period 3 (Weeks 49-72)
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets
Participants were asked "would you prefer to use the ring or the tablets for HIV prevention?" at their enrollment, Month 12, and product use end visit (Month 18) visits.
Measured: All three study periods (enrollment, month 12, and month 18 study visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start14 Jan 2019
- Primary completion9 Sep 2021
- Study completion9 Sep 2021
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 (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gonasagrie Nair, MBChB, MPH, Study chair, Emavundleni Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593655
- Sponsor's protocol ID
- MTN-034
- Other IDs
- 12066
- Status last verified
- Jan 2023
- First submitted
- 10 Jul 2018
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Friedland BA, Browne EN, Roberts ST, Ngure K, Nakalega R, Macdonald P, Mpongo CN, Tenza S, Mhlanga N, Szydlo D, Johnson S, McClure T, Nair G, Celum C, Hillier SL, van der Straten A; MTN-034 REACH clinical trial team. Higher Acceptability of the Monthly Dapivirine Ring Versus Daily Oral Pre-Exposure Prophylaxis Among Adolescent Girls and Young Women in Sub-Saharan Africa in the REACH Trial. J Acquir Immune Defic Syndr. 2025 Dec 15;100(5):415-424. doi: 10.1097/QAI.0000000000003756.
PubMed 40875480Shapley-Quinn MK, Tenza S, Jensen D, Tauya T, Mampuru L, Etima J, Kemigisha D, Atujuna M, Soto-Torres L, Johnson S, Mpongo N, Mhlanga N, Ngure K, van der Straten A. Adolescent Girls and Young Women Overcoming Adherence Challenges with Vaginal and Oral PrEP Use: A Longitudinal Qualitative Study from a Crossover Trial in South Africa, Uganda, and Zimbabwe. AIDS Behav. 2024 Dec;28(12):4209-4223. doi: 10.1007/s10461-024-04503-y. Epub 2024 Sep 30.
PubMed 39343865Nair G, Celum C, Szydlo D, Brown ER, Akello CA, Nakalega R, Macdonald P, Milan G, Palanee-Phillips T, Reddy K, Tahuringana E, Muhlanga F, Nakabiito C, Bekker LG, Siziba B, Hillier SL, Baeten JM, Garcia M, Johnson S, McClure T, Levy L, Livant E, Jacobson C, Soto-Torres L, van der Straten A, Hosek S, Rooney JF, Steytler J, Bunge K, Parikh U, Hendrix C, Anderson P, Ngure K; REACH Protocol Team. Adherence, safety, and choice of the monthly dapivirine vaginal ring or oral emtricitabine plus tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis among African adolescent girls and young women: a randomised, open-label, crossover trial. Lancet HIV. 2023 Dec;10(12):e779-e789. doi: 10.1016/S2352-3018(23)00227-8. Epub 2023 Oct 25.
PubMed 37898146Young AM, Mancuso N, Atujuna M, Tenza S, Chitukuta M, Kemigisha D, Ngure K, van der Straten A, Garcia M, Szydlo D, Soto-Torres L, Roberts ST. Adolescent Girls and Young Women's Experiences with Disclosing Oral PrEP or Dapivirine Vaginal Ring Use: a Multi-Country Qualitative Analysis. AIDS Behav. 2023 Dec;27(12):3941-3951. doi: 10.1007/s10461-023-04109-w. Epub 2023 Jul 1.
PubMed 37392268
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population
- ClinicalTrials.gov ID
- NCT03593655
- Acronym / sponsor ID
- MTN-034
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 3 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females.
Detailed description
This study will evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females.
The study will enroll healthy, HIV-uninfected adolescent and young adult females between 16 and 21 years of age. Participants will be randomized to one of two sequences of one VR containing 25 mg of dapivirine to be inserted monthly for 24 weeks and one 200 mg FTC/300 mg TDF oral tablet taken daily for 24 weeks. After completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. Participants will be able to choose either or neither study product during the third product use period. The study includes approximately 76 weeks of follow-up per participant.
Participants will attend monthly study visits, which may include behavioral assessments/counseling; physical and pelvic examinations; and blood, urine, and pelvic sample collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Dapivirine vaginal ring + FTC/TDF | Experimental | Device: Dapivirine vaginal ring, Drug: FTC/TDFParticipants will receive one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks. |
| Sequence B: FTC/TDF + Dapivirine vaginal ring | Experimental | Device: Dapivirine vaginal ring, Drug: FTC/TDFParticipants will receive one FTC/TDF oral tablet taken by mouth daily for 24 weeks, followed by one 25 mg dapivirine vaginal ring inserted vaginally each month for 24 weeks, followed by participant's choice of either or neither study product for 24 weeks. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Age 16 through 21 years (inclusive) at Enrollment, verified per site standard operating procedures (SOPs).
- Able and willing to provide informed consent, and if under the legal age of consent be able to provide informed assent and obtain parental or guardian permission/consent, to be screened for and to enroll in MTN-034 (as specified in site SOP).
- Able and willing to provide adequate locator information, as defined in site SOPs.
- Able and willing to comply with all study procedural requirements.
- Per participant report at Screening, post-menarche.
Key exclusion criteria (27 listed)
- Per participant report at Screening and Enrollment, intends to do any of the following during the study participation period:
- At Screening or Enrollment, has a positive HIV test.
- Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), sexually transmitted infection (STI) or reproductive tract infection (RTI) requiring treatment per World Health Organization (WHO) guidelines at Screening or Enrollment.
- At Enrollment, has a clinically apparent Grade 2 or higher pelvic exam finding.
- Participant report and/or clinical evidence of any of the following:
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 |
|---|---|---|
| Dapivirine vaginal ringVaginal ring containing 25 mg of dapivirine | Device | Sequence A: Dapivirine vaginal ring + FTC/TDF, Sequence B: FTC/TDF + Dapivirine vaginal ring |
| FTC/TDFAlso: Emtricitabine/Tenofovir Disoproxil Fumarate; TruvadaTablet containing 200 mg FTC/300 mg TDF | Drug | Sequence A: Dapivirine vaginal ring + FTC/TDF, Sequence B: FTC/TDF + Dapivirine vaginal ring |
Primary outcome
Number of Participants With Grade 2 or Higher Adverse Events (AEs)
Time frame: Study periods 1 and 2
During participants' first year on study (i.e., during first and second product use periods) participants were randomized to use either the dapivirine vaginal ring for 6 months followed by FTC/TDF for 6 months or vice versa. All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. AEs that were graded as at least Grade 2 (i.e., "moderate" or higher) were classified into the two periods based on reported date of AE onset, with AEs occurring between the participant's randomization date and the date 30 days after their Week 24 visit classified into Period 1, and AEs occurring between their Week 24 visit and the date 30 days after their Week 48 visit classified into Period 2. AEs occurring within 30 days of the Week 24 visit were counted in both periods. This is the number of participant-periods with at least one grade 2 or higher AE by product (combining the two product use periods).
Number of Participant-Visits With No Product Use
Time frame: Study periods 1 and 2
During the study period where participants were randomized to use FTC/TDF they were assessed for FTC/TDF adherence by dried blood spot (DBS) at monthly visits. Results that were below the lower limit of detection (< 16.6 fmol/punch) were classified as no use of FTC/TDF during the preceding month, and detectable results (>= 16.6 fmol/punch) classified as at least some FTC/TDF use. During the study period where participants were randomized to use the dapivirine vaginal ring (VR) they were assessed for ring adherence by residual drug levels in returned VRs. Results that were less than or equal to a rate of 0.9mg dapivirine released per month were classified as no use of the VR during that month, and results greater than 0.9mg dapivirine release per month classified as at least some VR use.
4 secondary outcomes
Number of Participant-Visits Reporting Acceptability of Study Product
Time frame: Study periods 1 and 2
Number of Participant-Visits With No Product Use
Time frame: Study period 3 (Weeks 49-72)
Number of Participants Selecting Each Study Product
Time frame: Study period 3 (Weeks 49-72)
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets
Time frame: All three study periods (enrollment, month 12, and month 18 study visits)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40875480Friedland BA, Browne EN, Roberts ST, Ngure K, Nakalega R, Macdonald P, Mpongo CN, Tenza S, Mhlanga N, Szydlo D, Johnson S, McClure T, Nair G, Celum C, Hillier SL, van der Straten A; MTN-034 REACH clinical trial team. Higher Acceptability of the Monthly Dapivirine Ring Versus Daily Oral Pre-Exposure Prophylaxis Among Adolescent Girls and Young Women in Sub-Saharan Africa in the REACH Trial. J Acquir Immune Defic Syndr. 2025 Dec 15;100(5):415-424. doi: 10.1097/QAI.0000000000003756.
- Derived from this study: PubMed 39343865Shapley-Quinn MK, Tenza S, Jensen D, Tauya T, Mampuru L, Etima J, Kemigisha D, Atujuna M, Soto-Torres L, Johnson S, Mpongo N, Mhlanga N, Ngure K, van der Straten A. Adolescent Girls and Young Women Overcoming Adherence Challenges with Vaginal and Oral PrEP Use: A Longitudinal Qualitative Study from a Crossover Trial in South Africa, Uganda, and Zimbabwe. AIDS Behav. 2024 Dec;28(12):4209-4223. doi: 10.1007/s10461-024-04503-y. Epub 2024 Sep 30.
- Derived from this study: PubMed 37898146Nair G, Celum C, Szydlo D, Brown ER, Akello CA, Nakalega R, Macdonald P, Milan G, Palanee-Phillips T, Reddy K, Tahuringana E, Muhlanga F, Nakabiito C, Bekker LG, Siziba B, Hillier SL, Baeten JM, Garcia M, Johnson S, McClure T, Levy L, Livant E, Jacobson C, Soto-Torres L, van der Straten A, Hosek S, Rooney JF, Steytler J, Bunge K, Parikh U, Hendrix C, Anderson P, Ngure K; REACH Protocol Team. Adherence, safety, and choice of the monthly dapivirine vaginal ring or oral emtricitabine plus tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis among African adolescent girls and young women: a randomised, open-label, crossover trial. Lancet HIV. 2023 Dec;10(12):e779-e789. doi: 10.1016/S2352-3018(23)00227-8. Epub 2023 Oct 25.
- Derived from this study: PubMed 37392268Young AM, Mancuso N, Atujuna M, Tenza S, Chitukuta M, Kemigisha D, Ngure K, van der Straten A, Garcia M, Szydlo D, Soto-Torres L, Roberts ST. Adolescent Girls and Young Women's Experiences with Disclosing Oral PrEP or Dapivirine Vaginal Ring Use: a Multi-Country Qualitative Analysis. AIDS Behav. 2023 Dec;27(12):3941-3951. doi: 10.1007/s10461-023-04109-w. Epub 2023 Jul 1.
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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.
Gonasagrie Nair, MBChB, MPH study chair
Emavundleni Research Centre
4 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 Dapivirine vaginal ring and FTC/TDF in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 16 inclusion and 27 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa, Uganda, Zimbabwe. 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 3 Feb 2023). 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?
Number of Participants With Grade 2 or Higher Adverse Events (AEs) (time frame: Study periods 1 and 2). The study lists 2 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 NCT03593655, which also lists 4 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 22 Jun 2023.