CompletedNCT03671239Updated Jan 20, 2023Results posted

Rectal Microbicide Acceptability, Tolerability and Adherence

An interventional study of Placebo rectal insert and Placebo rectal suppository in HIV Prevention, sponsored by Microbicide Trials Network. Completed at 7 sites in 5 countries. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-20.

Sponsored by Microbicide Trials Network · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 217
Allocation: Randomized
Ages: 18 Years to 35 Years
Sex: All

Study summary

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 studied

HIV Prevention

Keywords

Acceptability
Rectal microbicide

In context

Lead sponsor

Microbicide Trials Network is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 35 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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:
1. Hormonal methods;
2. Intrauterine device (IUD) inserted at least 30 days prior to Enrollment (but not past the maximum length of recommended usage according to package instructions);
3. Sterilization (of participant or, if in a monogamous relationship, of partner, as defined in site SOPs);
4. Abstinence from RVI for 90 days prior to Enrollment, and intention to abstain from RVI for the duration of study participation.

Exclusion criteria

Exclusion Criteria:

At Screening:
1. History of inflammatory bowel disease;
2. 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 design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 217 participants (actual)

Study arms

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.
Behavioral: Placebo rectal insert · Behavioral: Placebo rectal suppository · Behavioral: Placebo rectal douche
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.
Behavioral: Placebo rectal insert · Behavioral: Placebo rectal suppository · Behavioral: Placebo rectal douche
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.
Behavioral: Placebo rectal insert · Behavioral: Placebo rectal suppository · Behavioral: Placebo rectal douche
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.
Behavioral: Placebo rectal insert · Behavioral: Placebo rectal suppository · Behavioral: Placebo rectal douche
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.
Behavioral: Placebo rectal insert · Behavioral: Placebo rectal suppository · Behavioral: Placebo rectal douche
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.
Behavioral: Placebo rectal insert · Behavioral: Placebo rectal suppository · Behavioral: Placebo rectal douche

Interventions

BehavioralPlacebo rectal insert
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.
BehavioralPlacebo rectal suppository
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.
BehavioralPlacebo rectal douche
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.

What researchers measure

Primary outcomes

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

Results

Posted Jan 20, 2023

Limitations and caveats

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.

Participant flow

Recruitment took place at seven clinical research sites in four countries from April 2019 to March 2020

First Intervention (4 Weeks)

Participant flow — First Intervention (4 Weeks)
Milestone	Product Sequence A	Product Sequence B	Product Sequence C	Product Sequence D	Product Sequence E	Product Sequence F
Started	35	36	37	36	37	36
Completed	33	33	35	35	35	33
Not completed	2	3	2	1	2	3

Washout (1 Week)

Participant flow — Washout (1 Week)
Milestone	Product Sequence A	Product Sequence B	Product Sequence C	Product Sequence D	Product Sequence E	Product Sequence F
Started	35	36	37	36	37	36
Completed	35	36	37	36	37	36
Not completed	0	0	0	0	0	0

Second Intervetion (4 Weeks)

Participant flow — Second Intervetion (4 Weeks)
Milestone	Product Sequence A	Product Sequence B	Product Sequence C	Product Sequence D	Product Sequence E	Product Sequence F
Started	35	36	37	36	37	36
Completed	33	33	37	34	34	35
Not completed	2	3	0	2	3	1

Washout (1 Week)

Participant flow — Washout (1 Week)
Milestone	Product Sequence A	Product Sequence B	Product Sequence C	Product Sequence D	Product Sequence E	Product Sequence F
Started	35	36	37	36	37	36
Completed	35	36	37	36	37	36
Not completed	0	0	0	0	0	0

Third Intervention (4 Weeks)

Participant flow — Third Intervention (4 Weeks)
Milestone	Product Sequence A	Product Sequence B	Product Sequence C	Product Sequence D	Product Sequence E	Product Sequence F
Started	35	36	37	36	37	36
Completed	33	35	35	34	36	34
Not completed	2	1	2	2	1	2

Outcome measures

PrimaryAcceptability 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".

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

Acceptability of Future Product Use
Participants	Rectal Insert	Rectal Suppository	Rectal Douche
Yes	143	132	143
No	56	68	54
Missing	2	1	4

PrimaryAdherence to Placebo Products

Percentage of participants who used each study product as instructed

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

Adherence to Placebo Products
Participants	Rectal Insert	Rectal Suppository	Rectal Douche
Yes	150	148	165
No	49	51	35
Missing	2	2	1

PrimaryNumber 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

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

Number of Grade 2+ Related Adverse Events
Adverse events	Rectal Insert	Rectal Suppository	Rectal Douche
Number of Grade 2+ Related Adverse Events	2	0	0

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Rectal Insert	0/210 (0%)	0/210 (0%)	48/210 (22.9%)
Rectal Suppository	0/209 (0%)	0/209 (0%)	45/209 (21.5%)
Rectal Douche	0/210 (0%)	0/210 (0%)	48/210 (22.9%)

Most frequent other events

Showing 10 of 82

Most frequent other events
Event	Rectal Insert	Rectal Suppository	Rectal Douche
Anal chlamydia infectionInfections and infestations	4/210	5/209	7/210
Upper respiratory tract infectionInfections and infestations	3/210	5/209	1/210
Anorectal discomfortGastrointestinal disorders	5/210	2/209	0/210
DiarrheaGastrointestinal disorders	4/210	3/209	5/210
Oropharyngeal gonococcal infectionInfections and infestations	2/210	1/209	5/210
FlatulenceGastrointestinal disorders	4/210	1/209	2/210
NasopharyngitisInfections and infestations	4/210	1/209	4/210
Proctitis gonococcalInfections and infestations	3/210	3/209	3/210
Pharyngeal chlamydia infectionInfections and infestations	0/210	3/209	0/210
Abdominal painGastrointestinal disorders	3/210	0/209	1/210

Baseline characteristics

Age, Continuous
Age, Continuous(years)	All Study Participants
Mean	24.9 ± 4.7

Sex/Gender, Customized
Sex/Gender, Customized(Participants)	All Study Participants
Male	173
Female	2
Transgender Male	2
Transgender Female	19
Gender nonconforming/Variant	5
Other Gender	10
Multiple Genders	6

Sex: Female, Male
Sex: Female, Male(Participants)	All Study Participants
Female	3
Male	214

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	All Study Participants
Hispanic or Latino	13
Not Hispanic or Latino	83
Unknown or Not Reported	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	All Study Participants
Asian	8
Black or African American	16
Native Hawaiian or Other Pacific Islander	1
White	66
Multiple Races	33
Thai	30
Xhosa	5
Zulu	14
Other African Tribe	38
Other	6

Region of Enrollment
Region of Enrollment(Participants)	All Study Participants
United States	96
Malawi	31
South Africa	30
Thailand	30
Peru	30

Study locations

7 sites

Alabama Clinical Research Site
Birmingham, Alabama 35294, United States
Bridge HIV Clinical Research Site
San Francisco, California 94102, United States
University of Pittsburgh Clinical Research Site
Pittsburgh, Pennsylvania 15216, United States
Blantyre Clinical Research Site
Blantyre, Malawi
San Miguel Clinical Research Site
San Miguel, 15088, Peru
Wits Reproductive Health and HIV Institute Clinical Research Site
Johannesburg, 2038, South Africa
Chiang Mai University HIV Prevention Clinical Research Site
Chiang Mai, 50202, Thailand

References and documents

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

Study documents

Study protocol · Jun 15, 2018
Statistical analysis plan · Jan 25, 2021
Informed consent form · Jun 15, 2018

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03671239
Lead sponsor: Microbicide Trials 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)
Responsible party: Sponsor
First posted: Sep 14, 2018
Start date: Apr 26, 2019
Primary completion: Jul 27, 2020
Completion: Jul 27, 2020
Results posted: Jan 20, 2023
Last update: Jan 20, 2023

Study contacts

José A Bauermeister, PhD, MPH

study chair · University of Pennsylvania

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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