Rectal Microbicide Acceptability, Tolerability and Adherence

HIV Prevention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671239
• Other study ID #: MTN-035
• Secondary ID: UM1AI068633UM1AI
• Status: Completed
• Phase: N/A
• Start date: April 26, 2019
• Est. completion date: July 27, 2020

Study information

• Verified date: January 2023
• Source: Microbicide Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: July 27, 2020
• Est. primary completion date: July 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Men (cis or transgender) and TGW who are 18-35 years old at Screening, verified per site SOP.

2. Able and willing to provide written informed consent.

3. HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II and willing to receive HIV test results.

4. Able and willing to provide adequate locator information, as defined in site SOP.

5. Available to return for all study visits and willing to comply with study participation requirements.

6. In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee.

7. 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.

8. 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).

9. For individuals who can get pregnant (i.e., TGM with a female reproductive system): a negative pregnancy test at Screening and Enrollment.

10. 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:

1. 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.

2. 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.

3. Known adverse reaction to any of the components of the study products.

4. Participation in research studies involving drugs, medical devices, genital products, or vaccines within 30 days of the Enrollment Visit.

5. Participation in research studies involving rectal products (ever).

6. Per participant report, use of post-exposure prophylaxis (PEP) for potential HIV exposure within the 3 months prior to Enrollment.

7. 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).

8. 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).

9. Non-therapeutic injection drug use in the 12 months prior to Enrollment.

10. 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.

11. For individuals who can get pregnant: Pregnant or breastfeeding at either Screening or Enrollment or planning to become pregnant during study participation.

12. For individuals who can get pregnant: Last pregnancy outcome 90 days or less prior to Screening.

13. 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.

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Behavioral:
• Placebo 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.
• Placebo 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.
• Placebo 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.

Locations

Country	Name	City	State
Malawi	Blantyre Clinical Research Site	Blantyre
Peru	San Miguel Clinical Research Site	San Miguel
South Africa	Wits Reproductive Health and HIV Institute Clinical Research Site	Johannesburg
Thailand	Chiang Mai University HIV Prevention Clinical Research Site	Chiang Mai
United States	Alabama Clinical Research Site	Birmingham	Alabama
United States	University of Pittsburgh Clinical Research Site	Pittsburgh	Pennsylvania
United States	Bridge HIV Clinical Research Site	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
Microbicide Trials Network	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Malawi,  Peru,  South Africa,  Thailand, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	14 weeks (three 4-week product use periods with 1-week washout periods between them)
Primary	Adherence to Placebo Products	Percentage of participants who used each study product as instructed	14 weeks (three 4-week product use periods with 1-week washout periods between them)
Primary	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	14 weeks (three 4-week product use periods with 1-week washout periods between them)

External Links

•   Primary result abstract published by CROI