AcceptabilitySAMURAINCT05139563
South African Male User Research on Acceptability of Implants and Injections
A study of Acceptability, run by RTI International at 2 sites in South Africa.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acceptability
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 12 Jul 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Desmond Tutu Health Foundation, Philippi Village
Cape Town
Wits RHI
Johannesburg
About this study
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.
Read the detailed 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.
- Conditions
- Acceptability
- Being tested
- Placebo injection: Intralipid 20% fat emulsion, Placebo implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo injection: Intralipid 20% fat emulsionOther
placebo intralipid 20% intramuscular (IM) injection
Placebo implantOther
placebo subdermal implant rod
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo injection: Intralipid 20% fat emulsion; Other: Placebo implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Month 12
Adherence to study product regimen
Documentation of initiation and sustained use of placebo LA-PrEP study product
Measured: throughout study completion, average 1 year
Secondary outcomes (4)
Assessment of Adverse Events (AEs) for study product delivery methods
Number, relatedness, and severity of reported AEs and serious adverse events
Measured: throughout study completion, average 1 year
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
Measured: throughout study completion, average 1 year
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.
Measured: Month 12
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
Measured: throughout study completion, average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start12 Jul 2022
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcceptabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Montgomery, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139563
- Sponsor's protocol ID
- 00021779
- Other IDs
- 00021820
- Acronym
- SAMURAI
- Status last verified
- Apr 2025
- First submitted
- 4 Nov 2021
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South African Male User Research on Acceptability of Implants and Injections
- ClinicalTrials.gov ID
- NCT05139563
- Acronym / sponsor ID
- SAMURAI / 00021779
- Conditions
- Acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo injection | Sham comparator | Other: Placebo injection: Intralipid 20% fat emulsion, Other: Placebo implantThis group will first receive 3 mL intramuscular injections of a 20% fat emulsion (Intralipid 20%) every 2 months for 6 months. |
| Placebo implant | Experimental | Other: Placebo injection: Intralipid 20% fat emulsion, Other: Placebo implantThis 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo injection: Intralipid 20% fat emulsionplacebo intralipid 20% intramuscular (IM) injection | Other | Placebo implant, Placebo injection |
| Placebo implantplacebo subdermal implant rod | Other | Placebo implant, Placebo injection |
Primary outcome
Product initial attitudes rating (4-point Likert scale)
Time frame: Baseline
Assessment of participants' attitudes towards placebo long-acting (LA) PrEP study product physical attributes, expected ease of use, delivery method, and expected physical discomfort
Product satisfaction rating (4-point Likert scale)
Time frame: Month 6
Assessment of participants' satisfaction with placebo long-acting (LA) PrEP study product physical attributes, ease of use, delivery method, and physical discomfort
Product satisfaction rating (4-point Likert scale)
Time frame: Month 12
Assessment of participants' satisfaction with placebo long-acting (LA) PrEP study product physical attributes, ease of use, delivery method, and physical discomfort
Adherence to study product regimen
Time frame: throughout study completion, average 1 year
Documentation of initiation and sustained use of placebo LA-PrEP study product
4 secondary outcomes
Assessment of Adverse Events (AEs) for study product delivery methods
Time frame: throughout study completion, average 1 year
Assessment of Social Harms
Time frame: throughout study completion, average 1 year
Preference comparison for PrEP Delivery method
Time frame: Month 12
Burden of placebo product-specific pain
Time frame: throughout study completion, average 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Montgomery, PhD principal investigator
RTI International
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acceptability, run by RTI International at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Product initial attitudes rating (4-point Likert scale) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.