Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05139563
Other study ID # 00021779
Secondary ID 00021820
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 12, 2022
Est. completion date October 15, 2024

Study information

Verified date November 2023
Source RTI International
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Long-acting (LA) pre-exposure prophylaxis (PrEP) offers a promising alternative to existing HIV prevention methods. Research to assess end-user acceptability and actual experiences of novel delivery formulations has neglected, however, to include male perspectives, despite these products being appropriate for use by both men and women. This research aims to assess acceptability of and preferences for novel LA PrEP delivery formulation use among key end users: heterosexual men and men who have sex with men (MSM) in South Africa. Early involvement of men in product development is an important opportunity to measure and address product acceptability and foster male ownership of novel strategies, thereby enhancing potential effectiveness and impact, and broadening male engagement in HIV prevention. LA PrEP delivered by implant or injection addresses user preferences for simplicity, discretion, and longer dose duration. Currently, there are several PrEP implants in preclinical development and a few injectable formulations in early human phase trials. Biomedical strategies have two core components: the active pharmaceutical ingredient and the delivery mechanism; both of which contribute to acceptability and successful use of products. Research to assess acceptability of placebo use of LA PrEP delivery forms among end users provides insight that may apply to the many products under development. The contraceptive field provides substantial information about potential acceptability and use of LA delivery methods among women in sub-Saharan Africa (SSA). However, there is a gap in knowledge regarding acceptability of implant and injectable dosing platforms among men, particularly in SSA. The investigators propose a four-year study to comparatively examine acceptability and preferences of placebo implants and injectables using a crossover-designed mixed methods study among heterosexual men and MSM in Johannesburg and Cape Town, South Africa. The investigators hypothesize that men will find implant use acceptable as a delivery form and no less acceptable than intramuscular injections. First, formative qualitative research with men (n=40) will be conducted to assess knowledge and experiences and inform messages and materials for our Aim 2 and 3 work. Subsequently, a clinical crossover study will be conducted, in which men (n=200) will wear placebo implants for 6 months and have three bimonthly injections in a randomized sequence. Preferences for these delivery forms and product attributes of these LA methods, oral PrEP, and condoms will then be measured using a discrete choice experiment survey.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 184
Est. completion date October 15, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: 1. Being cis-gender male per self-identification 2. Aged 18-35 years 3. In good physical health, as determined by the site investigator or designee based on clinical history 4. Willing and able to comply with study procedures and attend follow-up visits over 1 year 5. Fluent in English, Xhosa, or Zulu 6. Sexually active, defined by receptive or insertive anal or vaginal intercourse at least once a month in the past 3 months 7. Able and willing to comply with all study procedural requirements 8. Able and willing to provide informed consent 9. Intention to stay within study catchment area for study duration and willingness to give adequate locator information 10. 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. Exclusion Criteria: 1. Known or suspected allergy to study product components (active or placebo), including egg or soy products (egg and soy products are contained in Intralipid). 2. At Screening or Enrollment, has a positive HIV test. 3. 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. Note: Genital warts requiring treatment and frequent recurrence of herpes simplex virus (HSV) are considered exclusionary; however, infrequent HSV outbreaks are not. Genital warts requiring treatment are defined as those that cause undue burden or discomfort to the participant, including bulky size, unacceptable appearance, or physical discomfort. 4. 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). 5. 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. 6. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Placebo injection: Intralipid 20% fat emulsion
placebo intralipid 20% intramuscular (IM) injection
Placebo implant
placebo subdermal implant rod

Locations

Country Name City State
South Africa Desmond Tutu Health Foundation, Philippi Village Cape Town
South Africa Wits RHI Johannesburg

Sponsors (1)

Lead Sponsor Collaborator
RTI International

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Adherence to study product regimen Documentation of initiation and sustained use of placebo LA-PrEP study product throughout study completion, average 1 year
Secondary Assessment of Adverse Events (AEs) for study product delivery methods Number, relatedness, and severity of reported AEs and serious adverse events throughout study completion, average 1 year
Secondary Assessment of Social Harms Number and severity of Social Harms (i.e., non-medical adverse consequences of participation such as discrimination, stigma, abuse, etc.) reported by participants throughout study completion, average 1 year
Secondary Preference comparison for PrEP Delivery method Self-comparison of participants' stated preferences of currently available and possible PrEP delivery methods [i.e., discrete choice experiment (DCE)] implemented at the exit clinical study visit. Investigators will assess preferences for implants as compared with injections; as well as preferences for product-specific attributes of each approach. Month 12
Secondary Burden of placebo product-specific pain Assessed by participant self-reported rating of physical pain from placebo product administration using a 10-point visual analogue scale throughout study completion, average 1 year
See also
  Status Clinical Trial Phase
Completed NCT06300034 - Parental Perceptions and Acceptance of Silver Diamine Fluoride in Italy
Completed NCT06384326 - Parental Perceptions and Acceptance of Silver Diamine Fluoride in Spain and Italy
Recruiting NCT06046053 - MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Vaginal Films Early Phase 1
Completed NCT02955563 - CSDM: A Trial to Improve Communication and Shared Decision Making Using a Web-Based Tool N/A
Completed NCT03556878 - Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment N/A
Completed NCT06320964 - The TARANG Intervention N/A
Completed NCT04391036 - Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations N/A
Active, not recruiting NCT05861076 - Moringa Powder Acceptability Trial Among Healthy Adults N/A
Active, not recruiting NCT06374316 - Air Purifiers in Classrooms for Infection Control - a Pilot Study N/A
Completed NCT04486677 - Caring Cards to and From Veterans: A Peer Approach to Suicide Prevention N/A
Recruiting NCT06163274 - Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings Early Phase 1