Clinical trial NCT06273696: Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania
Official title: Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penile Infection
Penile Haematoma
Penile Bleeding
Deformity
Keywords: male circumcision
ShangRing
adverse events
Tanzania
HIV/AIDS
nonsurgical circumcision
voluntary medical male circumcision
device
anesthesia
Lead sponsor: IntraHealth International
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Tanzania
name: President Office Regional Administration and Local Government, Tanzania
name: Centers for Disease Control and Prevention
name: Jhpiego
name: World Health Organization
First posted: 2024-02-22
Enrollment: 575
Sex: MALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Shinyanga is one of the 31 regions, in the Lake Zone Region of Tanzania. Shinyanga covers a total of 18,555 square kilometers. As of the 2012 census, the population of the Shinyanga region was 1,534,808. The economy of the region is primarily driven by agriculture. As of 2011, the HIV prevalence of Shinyanga was 7.4%. According to the Tanzania Demographic Health Survey and Malaria Indicator Survey, 54% of men in Shinyanga reported that they are circumcised.

Brief summary: The goal of this observational study was to evaluate the safety and acceptability of the ShangRing device for male circumcision among men in Shinyanga, Tanzania. The main question aims to answer both provider acceptability (practicality of device use and placement and removal times) and client acceptability (comfort during placement and removal, experience while wearing the ring, and penile appearance after healing). Participants voluntarily underwent male circumcision using the ShangRing device and before being discharged, were interviewed about their experience. Participants were also interviewed at device removal day (day 7), during a follow-up phone call (day 10), a sample were selected to participate in in-depth interviews (day28), and finally all men were asked to return for a follow-up visit (day 49).

Detailed description: Medical circumcision devices have the potential to accelerate delivery of male circumcision by making the procedure quicker and easier, while remaining as safe as surgical circumcision. Thus, circumcision devices may facilitate expansion of adult male circumcision programs for HIV prevention and address some of the common capacity issues in the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) priority countries for male circumcision.

One promising device for adult male circumcision is ShangRing, which was prequalified by the World Health Organization (WHO) in 2015 for males aged 13 and older. WHO has created a framework for introducing circumcision devices in a country. This framework recommends countries take a methodical approach to introducing circumcision devices, evaluating acceptability and safety within its health system before making widespread adoption.

Evaluation Goal: To evaluate the safety and acceptability of the ShangRing device for nonsurgical circumcision in routine clinical settings, as a part of a comprehensive HIV prevention program for males in voluntary medical male circumcisions (VMMC) programs.

Evaluation Endpoints: the proportion of males experiencing mild, moderate and severe adverse events (AEs) associated with ShangRing circumcision procedures, including both intra- and post-operative events, and all device-related malfunctions (e.g., early spontaneous detachment).

Evaluation Design

Training Phase: this phase was used to evaluate the training requirements for implementation by mid-level providers, to preliminarily assess acceptability to providers, and to monitor logistical needs. Each clinician performed no fewer than 10 ShangRing device placements, and 5 ShangRing removals before start of the next phase (implementation pilot).

Implementation Pilot: following the training period, 575 male clients were recruited to undergo circumcision with the ShangRing device in the context of routine service delivery.

Data was collected at up to at least 5 points in time: at enrollment and device placement (day 0), at device removal (day 7), during a follow-up phone call (day 10), in-depth qualitative interviews for 50 purposefully selected clients (day 28), at an in-person follow-up visit to assess wound healing (day 49), and at subsequent weekly visits to assess healing for those not completely healed at day 49. Upon completion of the implementation pilot, the data was analyzed and used to assist with policy decisions and recommendations on ShangRing use in adult male circumcision programs.

Eligibility criteria: Inclusion Criteria:

* Be an uncircumcised male aged 13 years or older
* Be seeking medical circumcision at one of the study sites
* Consent to an HIV test, unless they were known to be HIV-positive
* Agree to be circumcised using the ShangRing device
* Have their penis fit into one of the ShangRing ring sizes available during the study
* Be able to understand the evaluation procedures and requirements
* Agree to abstain from sexual intercourse and masturbation for six weeks after ring removal, for a total of seven weeks
* Live within 30 kilometers of the facility in Shinyanga Region, Tanzania
* Be willing to provide valid contact information (i.e., telephone number, address of residence, place of employment, and other locator information) and be willing to receive communications and/or follow-up visits
* Have an activated mobile phone or access to a mobile phone
* Agree to return for a follow-up visit to assess healing at day 49 (42 days post-removal)
* Agree to a ten-day post-placement (three days post-removal) telephone call to assess and detect symptoms of AEs
* Be able to communicate in English and/or Kiswahili
* Be capable and willing to provide written informed consent (18 years and older) or written informed consent from a parent guardian (13-17 years) to participate for both HIV testing services and VMMC services

Exclusion Criteria:

* A cognitive impairment that prevented the client from providing consent
* Any health condition (reported or observed) that was a contraindication to surgical VMMC in the national program or that ShangRing providers deemed a contraindication.

These may include diabetes, peripheral vascular disease, cancer, bleeding disorders, and/or current moderate or severe infectious illness.

* A current sexually transmitted infection (STI) other than HIV (clients with STIs were advised to return for circumcision once the STI was treated); and/or other conditions, which in the opinion of the site supervisor, prevented the client from undergoing a circumcision with the ShangRing device.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 49 days post device placement
measure: Number of Clients with Adverse Events
timeFrame: 49 days post device placement
measure: Descriptions of Adverse Events
timeFrame: 49 days post device placement
Secondary outcomes:
measure: Provider Training
timeFrame: 49 days post device placement
measure: Client Follow-up Visit Rate
timeFrame: 49 days post device placement
measure: Client Preference for ShangRing Over Surgical Circumcision
timeFrame: At device removal (7 days post device placement)
measure: Client Recommendation Rate
timeFrame: At device removal (7 days post device placement)
measure: Cosmetic Result Acceptability
timeFrame: At device removal (7 days post device placement)
measure: Client Experience While Performing Routine Activities
timeFrame: At device removal (7 days post device placement)
measure: Client Discomfort
timeFrame: At device removal (7 days post device placement)
measure: Provider Ease of Application
timeFrame: Immediately after the completion of the provider ShangRing training
measure: Provider Preference
timeFrame: Immediately after the completion of the provider ShangRing training
measure: Provider Recommendation
timeFrame: Immediately after the completion of the provider ShangRing training
measure: Description of Procedures
timeFrame: 49 days post device placement
measure: Healing rate
timeFrame: 52 days post device placement
Other outcomes:
Locations:
city: Shinyanga
country: Tanzania
facility: Kahama District Hospital
city: Shinyanga
country: Tanzania
facility: Ushetu Health Centre
Study officials:
affiliation: Head, HIV Prevention Unit, Tanzania Ministry of Health, Community Development, Gender and Children
name: Lija Gissenge, MD, MMed
role: PRINCIPAL_INVESTIGATOR
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