HIV PreventionNCT03671239

Rectal Microbicide Acceptability, Tolerability and Adherence

A study of HIV Prevention, run by Microbicide Trials Network at 7 sites in 5 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: HIV Prevention
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 217 participants
Where: 7 sitesin 5 countries
Study dates: 26 Apr 2019to 27 Jul 2020
Phase: Interventional
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 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Men (cis or transgender) and TGW who are 18-35 years old at Screening, verified per site SOP.
Able and willing to provide written informed consent.
HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II and willing to receive HIV test results.
Able and willing to provide adequate locator information, as defined in site SOP.
Available to return for all study visits and willing to comply with study participation requirements.
In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee.

Show all 14Show fewer

At Screening, history of consensual RAI at least three times in the past three months and expecting to maintain at least this frequency of RAI during study participation per participant report.
Willing to not take part in other research studies involving drugs, medical devices, genital or rectal products, or vaccines for the duration of study participation (including the time between Screening and Enrollment).
For individuals who can get pregnant (i.e., TGM with a female reproductive system): a negative pregnancy test at Screening and Enrollment.
For individuals who can get pregnant: Per participant report at Enrollment, using an effective method of contraception for at least 30 days (inclusive) prior to Enrollment and intending to use an effective method for the duration of study participation; effective methods include:
Hormonal methods;
Intrauterine device (IUD) inserted at least 30 days prior to Enrollment (but not past the maximum length of recommended usage according to package instructions);
Sterilization (of participant or, if in a monogamous relationship, of partner, as defined in site SOPs);
Abstinence from RVI for 90 days prior to Enrollment, and intention to abstain from RVI for the duration of study participation.

Who cannot join

At Screening:
History of inflammatory bowel disease;
Current anorectal condition that would impede product placement or assessment of tolerability by participant report or exam.
Anticipated use and/or unwillingness to abstain from using non-study rectally-administered medications and products during study participation, including personal lubricants containing nonoxynol-9 (N-9).
Note: The use of non-study personal lubricants and usual pre-RAI douches that do not contain N-9 is permitted during study participation.
Known adverse reaction to any of the components of the study products.

Show all 18Show fewer

Participation in research studies involving drugs, medical devices, genital products, or vaccines within 30 days of the Enrollment Visit.
Participation in research studies involving rectal products (ever).
Per participant report, use of post-exposure prophylaxis (PEP) for potential HIV exposure within the 3 months prior to Enrollment.
In the 3 months prior to Enrollment, participant engagement in condomless RAI or RVI while not on PrEP with a partner who is HIVpositive and either not on ART or of unknown ART use status (by self report).
In the month prior to Enrollment, participant engagement in condomless RAI or RVI while not on PrEP with a partner who is of unknown HIV status and unknown PrEP/ART use status (by self-report).
Non-therapeutic injection drug use in the 12 months prior to Enrollment.
At either Screening or Enrollment, participant-reported symptoms and/or clinical or laboratory diagnosis of active anorectal or reproductive tract infection (RTI) requiring treatment per current WHO guidelines (http://www.who.int/hiv/ pub/sti/pub6/en/), or symptomatic urinary tract infection (UTI). Infections requiring treatment include: Neisseria gonorrhea (GC), Chlamydia trachomatis (CT), syphilis, active herpes simplex virus (HSV) lesions, anogenital sores or ulcers, or symptomatic genital warts, chancroid, pelvic inflammatory disease (PID), symptomatic bacterial vaginosis (BV), symptomatic vaginal candidiasis, and trichomoniasis.
Note: Otherwise eligible participants with a symptomatic UTI or an STI/RTI requiring treatment per current WHO guidelines may be retested during the screening process and if treatment is completed and symptoms have resolved within the screening window the participant may be enrolled.
Note: HSV-1 or HSV-2 seropositive diagnosis with no active lesions is permitted since treatment is not required.
For individuals who can get pregnant: Pregnant or breastfeeding at either Screening or Enrollment or planning to become pregnant during study participation.
For individuals who can get pregnant: Last pregnancy outcome 90 days or less prior to Screening.
Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.

Trial locations and contacts

7 sites in 5 countries.

Country

City, postcode or hospital

7 sites in 5 countries

United States3 sites

Alabama Clinical Research Site
Birmingham, Alabama, 35294
University of Pittsburgh Clinical Research Site
Pittsburgh, Pennsylvania, 15216
Bridge HIV Clinical Research Site
San Francisco, California, 94102

Other trials in United States

Malawi1 site

Blantyre Clinical Research Site
Blantyre

Other trials in Malawi

Peru1 site

San Miguel Clinical Research Site
San Miguel, 15088

Other trials in Peru

South Africa1 site

Wits Reproductive Health and HIV Institute Clinical Research Site
Johannesburg, 2038

Other trials in South Africa

Thailand1 site

Chiang Mai University HIV Prevention Clinical Research Site
Chiang Mai, 50202

Other trials in Thailand

About this study

Official title: Acceptability, Tolerability, and Adherence of Three Rectal Microbicide Placebo Formulations Among HIV Seronegative Cisgender Men, Transgender Men and Transgender Women Who Engage in Receptive Anal Intercourse

Read the detailed description

MTN-035 is a multi-site, randomized-sequence, three-period, open label crossover study that will enroll approximately 210 participants randomized (1:1:1:1:1:1) to one of six sequences of rectal microbicide placebo product application. At the start of each 4-week product use period, participants will receive either rectal inserts, rectal douches, or rectal suppositories and be instructed to use their assigned study product prior to each receptive anal intercourse (RAI) encounter during that period. Participants who do not have RAI in a given week will be asked to use the product without sex. There will be a 1-week washout period between each of the three product use periods. Participant follow-up will take approximately 3.5 months.

Conditions: HIV Prevention
Being tested: Placebo rectal insert, Placebo rectal suppository, Placebo rectal douche
Keywords: Acceptability, Rectal microbicide

What participants receive

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

Placebo rectal insertBehavioural
Participants will be instructed to insert in the rectum a placebo insert prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.
Placebo rectal suppositoryBehavioural
Participants will be instructed to insert in the rectum a placebo suppository prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.
Placebo rectal doucheBehavioural
Participants will be instructed to insert in the rectum a placebo douche (enema bottle with approximately 120 mL of clean tap water or bottled water) prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI, or if no other RAI activity occurs in that 7-day period, to take a dose in the absence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.

Study groups in NCT03671239
Study group	Role	What they receive
Product Sequence A	Other	Participants will use placebo rectal inserts during the first 4-week product use period, placebo rectal douches during the second 4-week product use period, and placebo rectal suppositories during the third and final 4-week product use period. Receives: Behavioral: Placebo rectal insert; Behavioral: Placebo rectal suppository; Behavioral: Placebo rectal douche
Product Sequence B	Other	Participants will use placebo rectal douches during the first 4-week product use period, placebo rectal suppositories during the second 4-week product use period, and placebo rectal inserts during the third and final 4-week product use period. Receives: Behavioral: Placebo rectal insert; Behavioral: Placebo rectal suppository; Behavioral: Placebo rectal douche
Product Sequence C	Other	Participants will use rectal suppositories during the first 4-week product use period, rectal inserts during the second 4-week product use period, and rectal douches during the third and final 4-week product use period. Receives: Behavioral: Placebo rectal insert; Behavioral: Placebo rectal suppository; Behavioral: Placebo rectal douche
Product Sequence D	Other	Participants will use placebo rectal inserts during the first 4-week product use period, placebo rectal suppositories during the second 4-week product use period, and placebo rectal douches during the third and final 4-week product use period. Receives: Behavioral: Placebo rectal insert; Behavioral: Placebo rectal suppository; Behavioral: Placebo rectal douche
Product Sequence E	Other	Participants will use placebo rectal douches during the first 4-week product use period, placebo rectal inserts during the second 4-week product use period, and placebo rectal suppositories during the third and final 4-week product use period. Receives: Behavioral: Placebo rectal insert; Behavioral: Placebo rectal suppository; Behavioral: Placebo rectal douche
Product Sequence F	Other	Participants will use placebo rectal suppositories during the first 4-week product use period, placebo rectal douches during the second 4-week product use period, and placebo rectal inserts during the third and final 4-week product use period. Receives: Behavioral: Placebo rectal insert; Behavioral: Placebo rectal suppository; Behavioral: Placebo rectal douche

What is being measured

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

Acceptability of Future Product Use
Using a 10-point scale (1=Very Unlikely; 10=Very Likely), participants were asked to answer the following question about their most recently used product: "Think about the positive and negative experiences you have had using the [study product] during the past 4-week period. If this [study product] was available and it provided some protection against HIV, how likely would you be to use it before receptive anal sex?". The endpoint was operationalized as binary, with scores 1 to 6 grouped as "low acceptability" and scores 7 to 10 as "high acceptability".
Measured: 14 weeks (three 4-week product use periods with 1-week washout periods between them)
Adherence to Placebo Products
Percentage of participants who used each study product as instructed
Measured: 14 weeks (three 4-week product use periods with 1-week washout periods between them)
Number of Grade 2+ Related Adverse Events
Number of all Grade 2 or higher related adverse events (AE) reported in the study as defined by the DAIDS AE Grading Table
Measured: 14 weeks (three 4-week product use periods with 1-week washout periods between them)

Timeline

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

26 Apr 201927 Jul 2020

First posted14 Sep 2018
Study start26 Apr 2019
Primary completion27 Jul 2020
Study completion27 Jul 2020

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 (3)Papers the sponsor has linked to this study.
Other trials for HIV PreventionStudies 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03671239
Sponsor's protocol ID: MTN-035
Other IDs: UM1AI068633, UM1AI068615, UM1AI106707, 38459
Status last verified: Jan 2023
First submitted: 23 Aug 2018
Last updated: 20 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Bauermeister J, Tingler R, Liu A, Chariyalertsak S, Hoesley C, Gonzales P, et al. Acceptability and choice for three placebo products used with receptive anal sex. Conference on Retroviruses and Opportunistic Infections (CROI), Mar 6-10, 2021; Abstract # 716
Bauermeister J, Lin W, Tingler R, Liu A, Chariyalertsak S, Hoesley C, Gonzales P, Ho K, Kayange N, Phillips TP, Johnson S, Brown E, Zemanek J, Jacobson CE, Doncel GF, Piper J; MTN-035 Protocol Team for the Microbicide Trials Network. A conjoint experiment of three placebo rectal products used with receptive anal sex: results from MTN-035. J Int AIDS Soc. 2024 Mar;27(3):e26219. doi: 10.1002/jia2.26219.
PubMed 38494656
Choi SK, Bauermeister J, Tingler RC, Johnson S, Macagna N, Ho K, Hoesley C, Liu A, Kayange N, Palanee-Phillips T, Chariyalertsak S, Gonzales P, Piper JM; MTN-035 Protocol Team. A latent trajectory analysis of young sexual and gender minorities' adherence to three rectal microbicide placebo formulations (MTN-035; a randomized crossover trial). BMC Public Health. 2023 Dec 8;23(1):2464. doi: 10.1186/s12889-023-17368-y.
PubMed 38066471

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 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acceptability, Tolerability, and Adherence of Three Rectal Microbicide Placebo Formulations Among HIV Seronegative Cisgender Men, Transgender Men and Transgender Women Who Engage in Receptive Anal Intercourse
ClinicalTrials.gov ID: NCT03671239
Acronym / sponsor ID: MTN-035
Conditions: HIV Prevention
Keywords: Acceptability, Rectal microbicide
Study type: Interventional
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: Microbicide Trials NetworkResearch network
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
Study start: 26 Apr 2019 (actual)
Primary completion: 27 Jul 2020 (actual)
Study completion: 27 Jul 2020 (actual)
First posted: 14 Sep 2018 (actual)
Results: Posted 20 Jan 2023

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: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Product Sequence A	Other	Behavioral: Placebo rectal insert, Behavioral: Placebo rectal suppository, Behavioral: Placebo rectal doucheParticipants will use placebo rectal inserts during the first 4-week product use period, placebo rectal douches during the second 4-week product use period, and placebo rectal suppositories during the third and final 4-week product use period.
Product Sequence B	Other	Behavioral: Placebo rectal insert, Behavioral: Placebo rectal suppository, Behavioral: Placebo rectal doucheParticipants will use placebo rectal douches during the first 4-week product use period, placebo rectal suppositories during the second 4-week product use period, and placebo rectal inserts during the third and final 4-week product use period.
Product Sequence C	Other	Behavioral: Placebo rectal insert, Behavioral: Placebo rectal suppository, Behavioral: Placebo rectal doucheParticipants will use rectal suppositories during the first 4-week product use period, rectal inserts during the second 4-week product use period, and rectal douches during the third and final 4-week product use period.
Product Sequence D	Other	Behavioral: Placebo rectal insert, Behavioral: Placebo rectal suppository, Behavioral: Placebo rectal doucheParticipants will use placebo rectal inserts during the first 4-week product use period, placebo rectal suppositories during the second 4-week product use period, and placebo rectal douches during the third and final 4-week product use period.
Product Sequence E	Other	Behavioral: Placebo rectal insert, Behavioral: Placebo rectal suppository, Behavioral: Placebo rectal doucheParticipants will use placebo rectal douches during the first 4-week product use period, placebo rectal inserts during the second 4-week product use period, and placebo rectal suppositories during the third and final 4-week product use period.
Product Sequence F	Other	Behavioral: Placebo rectal insert, Behavioral: Placebo rectal suppository, Behavioral: Placebo rectal doucheParticipants will use placebo rectal suppositories during the first 4-week product use period, placebo rectal douches during the second 4-week product use period, and placebo rectal inserts during the third and final 4-week product use period.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Men (cis or transgender) and TGW who are 18-35 years old at Screening, verified per site SOP.
Able and willing to provide written informed consent.
HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II and willing to receive HIV test results.
Able and willing to provide adequate locator information, as defined in site SOP.
Available to return for all study visits and willing to comply with study participation requirements.

Key exclusion criteria (18 listed)

At Screening:
Anticipated use and/or unwillingness to abstain from using non-study rectally-administered medications and products during study participation, including personal lubricants containing nonoxynol-9 (N-9).
Note: The use of non-study personal lubricants and usual pre-RAI douches that do not contain N-9 is permitted during study participation.
Known adverse reaction to any of the components of the study products.
Participation in research studies involving drugs, medical devices, genital products, or vaccines within 30 days of the Enrollment Visit.

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
Placebo rectal insertParticipants will be instructed to insert in the rectum a placebo insert prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.	Behavioural	Product Sequence A, Product Sequence B, Product Sequence C, Product Sequence D, Product Sequence E, Product Sequence F
Placebo rectal suppositoryParticipants will be instructed to insert in the rectum a placebo suppository prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.	Behavioural	Product Sequence A, Product Sequence B, Product Sequence C, Product Sequence D, Product Sequence E, Product Sequence F
Placebo rectal doucheParticipants will be instructed to insert in the rectum a placebo douche (enema bottle with approximately 120 mL of clean tap water or bottled water) prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI, or if no other RAI activity occurs in that 7-day period, to take a dose in the absence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.	Behavioural	Product Sequence A, Product Sequence B, Product Sequence C, Product Sequence D, Product Sequence E, Product Sequence F

Primary outcome

Acceptability of Future Product Use
Time frame: 14 weeks (three 4-week product use periods with 1-week washout periods between them)
Using a 10-point scale (1=Very Unlikely; 10=Very Likely), participants were asked to answer the following question about their most recently used product: "Think about the positive and negative experiences you have had using the [study product] during the past 4-week period. If this [study product] was available and it provided some protection against HIV, how likely would you be to use it before receptive anal sex?". The endpoint was operationalized as binary, with scores 1 to 6 grouped as "low acceptability" and scores 7 to 10 as "high acceptability".
Adherence to Placebo Products
Time frame: 14 weeks (three 4-week product use periods with 1-week washout periods between them)
Percentage of participants who used each study product as instructed
Number of Grade 2+ Related Adverse Events
Time frame: 14 weeks (three 4-week product use periods with 1-week washout periods between them)
Number of all Grade 2 or higher related adverse events (AE) reported in the study as defined by the DAIDS AE Grading Table

Results and safety

Results posted to the registry on 20 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Product Sequence A	35	33
Product Sequence B	36	33
Product Sequence C	37	35
Product Sequence D	36	35
Product Sequence E	37	35
Product Sequence F	36	33

Primary outcome: Acceptability of Future Product Use

Time frame: 14 weeks (three 4-week product use periods with 1-week washout periods between them). Count of participants. Unit: Participants

Measure	Rectal Insert n = 201	Rectal Suppository n = 201	Rectal Douche n = 201
Yes	143	132	143
No	56	68	54
Missing	2	1	4

Primary outcome: Adherence to Placebo Products

Time frame: 14 weeks (three 4-week product use periods with 1-week washout periods between them). Count of participants. Unit: Participants

Measure	Rectal Insert n = 201	Rectal Suppository n = 201	Rectal Douche n = 201
Yes	150	148	165
No	49	51	35
Missing	2	2	1

Primary outcome: Number of Grade 2+ Related Adverse Events

Time frame: 14 weeks (three 4-week product use periods with 1-week washout periods between them). Number. Unit: Adverse events

Measure	Rectal Insert n = 210	Rectal Suppository n = 209	Rectal Douche n = 210
Value	2	0	0

Adverse events

Time frame: Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rectal Insert	0 of 210 (0%)	48 of 210 (22.9%)	0 of 210
Rectal Suppository	0 of 209 (0%)	45 of 209 (21.5%)	0 of 209
Rectal Douche	0 of 210 (0%)	48 of 210 (22.9%)	0 of 210

Limitations and caveats (from the sponsor): First, self-reported responses tend to be favorable due to social desirability. Second, we recruited a convenience sample of participants willing to use each of the study products at least once per week as required by the protocol. Third, given the placebo nature of the three products used in our trial, we were unable to employ a biological confirmation method regarding participants' product use and adherence. Finally, we were unable to recruit the sexual partners of our study participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundBauermeister J, Tingler R, Liu A, Chariyalertsak S, Hoesley C, Gonzales P, et al. Acceptability and choice for three placebo products used with receptive anal sex. Conference on Retroviruses and Opportunistic Infections (CROI), Mar 6-10, 2021; Abstract # 716
Derived from this study: PubMed 38494656Bauermeister J, Lin W, Tingler R, Liu A, Chariyalertsak S, Hoesley C, Gonzales P, Ho K, Kayange N, Phillips TP, Johnson S, Brown E, Zemanek J, Jacobson CE, Doncel GF, Piper J; MTN-035 Protocol Team for the Microbicide Trials Network. A conjoint experiment of three placebo rectal products used with receptive anal sex: results from MTN-035. J Int AIDS Soc. 2024 Mar;27(3):e26219. doi: 10.1002/jia2.26219.
Derived from this study: PubMed 38066471Choi SK, Bauermeister J, Tingler RC, Johnson S, Macagna N, Ho K, Hoesley C, Liu A, Kayange N, Palanee-Phillips T, Chariyalertsak S, Gonzales P, Piper JM; MTN-035 Protocol Team. A latent trajectory analysis of young sexual and gender minorities' adherence to three rectal microbicide placebo formulations (MTN-035; a randomized crossover trial). BMC Public Health. 2023 Dec 8;23(1):2464. doi: 10.1186/s12889-023-17368-y.
Primary result abstract published by CROILink provided by the sponsor.

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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.

José A Bauermeister, PhD, MPH study chair

University of Pennsylvania

7 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of HIV Prevention, run by Microbicide Trials Network at 7 sites in 5 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 14 inclusion and 18 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 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Malawi, Peru, 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 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?

Acceptability of Future Product Use (time frame: 14 weeks (three 4-week product use periods with 1-week washout periods between them)). The study lists 3 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 NCT03671239, which also lists 3 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 20 Jan 2023.