HIV PreventionNCT03132285
Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placement of Device
A study testing PrePex in people with HIV Prevention, run by Ministry of Health, Zambia at 2 sites in Zambia.
Trial summary
To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement. Read more about this study
- Who is it for?
- Ages 13 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- PrePex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesZambia
- Study dates
- 11 Mar 2017to 17 Jun 2017
- 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 13 to 49 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages - 13 to 49 years
- Uncircumcised
- Participant wants to be circumcised
- Participant assent to the procedure
- Legal guardian consent to the procedure for ages 13-18 years
- Able to understand the study procedures and requirements
Show all 10Show fewer
- Agrees to abstain from sexual intercourse for 8 weeks after circumcision
- Agrees to abstain from masturbation for at least 2 weeks after Removal
- Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 weeks total)
- Participant able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
Who cannot join
- Legal guardian withholds consent for ages 13-18 years
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the participant from undergoing a circumcision
- Participant with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Participant that to the opinion of the investigator is not a good candidate
- Diabetes Mellitus
- HIV Sero-positive
Trial locations and contacts
2 sites in 1 country.
Zambia2 sites
Dambwa North Clinic
Livingstone
Matero Main Clinic
Lusaka, Lusaka Province
About this study
Official title: Safety and Acceptability Study of Non-Surgical Male Circumcision Device for Adult Male Population When Removing the Foreskin Shortly After Placement of Device Performed at Lusaka and Livingstone, Zambia
To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.
Read the detailed description
To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.
Five hundred (500) males scheduled for voluntary circumcision performed by clinicians or nurses using the PrePex.
Theses clinicians and nurses have already been trained in the Prepex procedure and will undergo further training in the modification to the technique. Study duration per participant will be up to 8 weeks and will include three follow up visits and one phone call follow up.
- Conditions
- HIV Prevention
- Being tested
- PrePex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrePexDevice
Prepex is a non surgical male circumcision device
| Study group | Role | What they receive |
|---|---|---|
| PrePex Day 0 foreskin removal | Other | Day 0 foreskin removal Receives: Device: PrePex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incidents related to the change in procedure
To assess the safety of PrePex device when removing the foreskin shortly after device placement by means of the following parameter: Incidence of Serious Adverse Events, when performed by clinicians and nurses
Measured: 8 weeks
Acceptability of the changes procedure to patients
To asses the new procedure acceptability for patients using the following measures - Evaluation of pain during foreskin removal
- Patients willingness to wait for foreskin removal
- Odour while device is in situ
- Pain at key time points on Removal visit
- Discomfort of any type to patients.
Measured: 8 weeks
Secondary outcomes (1)
Effect of the change in procedure on circumcision healing time
To assess the circumcision healing time period.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start11 Mar 2017
- Primary completion22 Apr 2017
- Study completion17 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Zambia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Linyama, Ministry of Health, Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132285
- Sponsor's protocol ID
- 0001
- Status last verified
- Sep 2017
- First submitted
- 4 Apr 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Acceptability Study of Non-Surgical Male Circumcision Device for Adult Male Population When Removing the Foreskin Shortly After Placement of Device Performed at Lusaka and Livingstone, Zambia
- ClinicalTrials.gov ID
- NCT03132285
- Acronym / sponsor ID
- 0001
- Conditions
- HIV Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ministry of Health, ZambiaOther government
- Study start
- 11 Mar 2017 (actual)
- Primary completion
- 22 Apr 2017 (actual)
- Study completion
- 17 Jun 2017 (actual)
- First posted
- 27 Apr 2017 (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.
To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.
Detailed description
To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.
Five hundred (500) males scheduled for voluntary circumcision performed by clinicians or nurses using the PrePex.
Theses clinicians and nurses have already been trained in the Prepex procedure and will undergo further training in the modification to the technique. Study duration per participant will be up to 8 weeks and will include three follow up visits and one phone call follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrePex Day 0 foreskin removal | Other | Device: PrePexDay 0 foreskin removal |
Who may qualify
- Ages
- 13 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Ages - 13 to 49 years
- Uncircumcised
- Participant wants to be circumcised
- Participant assent to the procedure
- Legal guardian consent to the procedure for ages 13-18 years
Key exclusion criteria (7 listed)
- Legal guardian withholds consent for ages 13-18 years
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the participant from undergoing a circumcision
- Participant with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Participant that to the opinion of the investigator is not a good candidate
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 |
|---|---|---|
| PrePexPrepex is a non surgical male circumcision device | Device | PrePex Day 0 foreskin removal |
Primary outcome
Number of incidents related to the change in procedure
Time frame: 8 weeks
To assess the safety of PrePex device when removing the foreskin shortly after device placement by means of the following parameter: Incidence of Serious Adverse Events, when performed by clinicians and nurses
Acceptability of the changes procedure to patients
Time frame: 8 weeks
To asses the new procedure acceptability for patients using the following measures - Evaluation of pain during foreskin removal * Patients willingness to wait for foreskin removal * Odour while device is in situ * Pain at key time points on Removal visit * Discomfort of any type to patients.
1 secondary outcome
Effect of the change in procedure on circumcision healing time
Time frame: 8 weeks
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 7 Sep 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrePex in people with HIV Prevention, run by Ministry of Health, Zambia at 2 sites in Zambia.
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 7 Sep 2017. 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 Zambia. 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. 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?
Number of incidents related to the change in procedure (time frame: 8 weeks). The study lists 2 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 7 Sep 2017.