South African Male User Research on Acceptability of Implants and Injections

NCT05139563 | Completed DMC

• 2 other identifiers: 0002177900021820
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 2

Brief Summary

The overall aims of SAMURAI (South African Male User Research on Acceptability of Implants and Injections) are to assess acceptability of, and preferences for, novel long-acting pre-exposure prophylaxis (LA-PrEP) delivery formulation use among key end-users: heterosexual men and men-who-have-sex-with-men (MSM) in South Africa, a country most impacted by human immunodeficiency virus (HIV) incidence and prevalence. Early involvement of men in product development is an important opportunity to measure and address product acceptability and factors that may influence adherence and to foster male ownership of novel HIV prevention delivery modalities.

Conditions

Acceptability

Outcome Measures

Primary Outcomes (4)

• Product initial attitudes rating (4-point Likert scale)

  Assessment of participants' attitudes towards placebo long-acting (LA) PrEP study product physical attributes, expected ease of use, delivery method, and expected physical discomfort

  Baseline

• Product satisfaction rating (4-point Likert scale)

  Assessment of participants' satisfaction with placebo long-acting (LA) PrEP study product physical attributes, ease of use, delivery method, and physical discomfort

  Month 6

• Product satisfaction rating (4-point Likert scale)

  Assessment of participants' satisfaction with placebo long-acting (LA) PrEP study product physical attributes, ease of use, delivery method, and physical discomfort

  Month 12

• Adherence to study product regimen

  Documentation of initiation and sustained use of placebo LA-PrEP study product

  throughout study completion, average 1 year

Secondary Outcomes (4)

• Assessment of Adverse Events (AEs) for study product delivery methods

  throughout study completion, average 1 year

• Assessment of Social Harms

  throughout study completion, average 1 year

• Preference comparison for PrEP Delivery method

  Month 12

• Burden of placebo product-specific pain

  throughout study completion, average 1 year

Study Arms (2)

Placebo injection

SHAM COMPARATOR

This group will first receive 3 mL intramuscular injections of a 20% fat emulsion (Intralipid 20%) every 2 months for 6 months.

Other: Placebo injection: Intralipid 20% fat emulsion; Other: Placebo implant

Placebo implant

EXPERIMENTAL

This group will first receive a single-use subdermal implant in the inner side of the upper arm for a duration of 6 months before removal.

Other: Placebo injection: Intralipid 20% fat emulsion; Other: Placebo implant

Interventions

Placebo injection: Intralipid 20% fat emulsion OTHER

placebo intralipid 20% intramuscular (IM) injection

Placebo implant; Placebo injection

Placebo implant OTHER

placebo subdermal implant rod

Placebo implant; Placebo injection

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Cisgender men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being cis-gender male per self-identification
• Aged 18-35 years
• In good physical health, as determined by the site investigator or designee based on clinical history
• Willing and able to comply with study procedures and attend follow-up visits over 1 year
• Fluent in English, Xhosa, or Zulu
• Sexually active, defined by receptive or insertive anal or vaginal intercourse at least once a month in the past 3 months
• Able and willing to comply with all study procedural requirements
• Able and willing to provide informed consent
• Intention to stay within study catchment area for study duration and willingness to give adequate locator information
• At Screening and Enrollment, states a willingness to refrain from participation in other research studies involving drugs, vaccines, or medical devices during study participation. Participation in other behavioral studies is subject to Investigator discretion.

You may not qualify if:

• Known or suspected allergy to study product components (active or placebo), including egg or soy products (egg and soy products are contained in Intralipid).
• At Screening or Enrollment, has a positive HIV test.
• Diagnosed or suspected sexually transmitted infection (STI) requiring treatment at Enrollment such as gonorrhea (GC), chlamydia, trichomonas, and/or syphilis. Enrollment will be considered after treatment of STIs.
• As determined by the Investigator/designee, any current or historical physical or mental health condition that the site investigator or designee determines should exclude participation (for example, injection drug use within the past year).
• Has any other condition that, in the opinion of the Investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
• At Enrollment, participant reports current or recent (30 days or less prior to enrollment) participation in any research study involving drugs, vaccines, or medical devices. Allowance for co-enrollment in other types of studies is indicated below.

Sponsors & Collaborators

• RTI International: lead

Study Sites (2)

Desmond Tutu Health Foundation, Philippi Village

Cape Town, South Africa

Location

Wits RHI

Johannesburg, South Africa

Location

MeSH Terms

Interventions

soybean oil, phospholipid emulsion

Study Officials

• Elizabeth Montgomery, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 1, 2021
• Study Start: July 12, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

ZA (2)