- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03671239
Rectal Microbicide Acceptability, Tolerability and Adherence
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Blantyre, Malawi
- Blantyre Clinical Research Site
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San Miguel, Peru, 15088
- San Miguel Clinical Research Site
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Johannesburg, South Africa, 2038
- Wits Reproductive Health and HIV Institute Clinical Research Site
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Chiang Mai, Thailand, 50202
- Chiang Mai University HIV Prevention Clinical Research Site
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Alabama
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Birmingham, Alabama, United States, 35294
- Alabama Clinical Research Site
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California
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San Francisco, California, United States, 94102
- Bridge HIV Clinical Research Site
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15216
- University of Pittsburgh Clinical Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Product Sequence A
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.
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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.
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.
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.
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Other: Product Sequence B
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.
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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.
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.
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.
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Other: Product Sequence C
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.
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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.
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.
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.
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Other: Product Sequence D
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.
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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.
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.
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.
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Other: Product Sequence E
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.
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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.
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.
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.
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Other: Product Sequence F
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.
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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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Acceptability of Future Product Use
Time Frame: 14 weeks (three 4-week product use periods with 1-week washout periods between them)
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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".
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14 weeks (three 4-week product use periods with 1-week washout periods between them)
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Adherence to Placebo Products
Time Frame: 14 weeks (three 4-week product use periods with 1-week washout periods between them)
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Percentage of participants who used each study product as instructed
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14 weeks (three 4-week product use periods with 1-week washout periods between them)
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Number of Grade 2+ Related Adverse Events
Time Frame: 14 weeks (three 4-week product use periods with 1-week washout periods between them)
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Number of all Grade 2 or higher related adverse events (AE) reported in the study as defined by the DAIDS AE Grading Table
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14 weeks (three 4-week product use periods with 1-week washout periods between them)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: José A Bauermeister, PhD, MPH, University of Pennsylvania
Publications and helpful links
General 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
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MTN-035
- UM1AI068633 (U.S. NIH Grant/Contract)
- UM1AI068615 (U.S. NIH Grant/Contract)
- UM1AI106707 (U.S. NIH Grant/Contract)
- 38459 (Other Identifier: DAIDS)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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