HIV InfectionsVMMC-RITeNCT04677374
Uptake of Medical Male Circumcision Among Men With Sexually Transmitted Infections
A study testing Intensified Health Education, SMS/telephonic Tracing and Transportation Reimbursement in people with HIV Infections and Sexually Transmitted Infections, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial summary
The intervention includes provision of transport reimbursement for men who will undergo voluntary medical male circumcision (VMMC), intensified health education by a VMMC mobilizer and a male and female VMMC champion and use of a cell phone short messaging service (SMS) and/or telephonic tracing to remind clients of… Read more about this study
- Who is it for?
- Ages 18 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Infections
- What is being tested?
- Intensified Health Education, SMS/telephonic Tracing and Transportation Reimbursement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,242 participants
- Where
- 1 siteMalawi
- Study dates
- 1 Feb 2021to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- 18 years or older
- Seeking STI care at the Bwaila STI clinic
- Not circumcised
- Healthcare workers at Bwaila STI and VMMC clinic
Who cannot join
- < 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uptake of Voluntary Medical Male Circumcision Among Men Attending a Sexually Transmitted Infections Clinic in Lilongwe, Malawi
The intervention includes provision of transport reimbursement for men who will undergo voluntary medical male circumcision (VMMC), intensified health education by a VMMC mobilizer and a male and female VMMC champion and use of a cell phone short messaging service (SMS) and/or telephonic tracing to remind clients of their VMMC appointment (the RITe intervention). The investigators will assess the uptake of VMMC, and acceptability, appropriateness and feasibility of the RITe intervention among uncircumcised men attending a Sexually Transmitted Infection (STI) clinic and health care workers.
This intervention was initially designed to include escorting men interested in circumcision from the STI clinic to a VMMC clinic co-located in the same facility. However, the VMMC clinic space was repurposed to a COVID-19 isolation unit therefore clinic escorts were excluded. In Lieu of clinic escorts, participants will be linked to the nearest health facility of choice where VMMC services are provided by the VMMC mobilizer.
The purpose of the study is to evaluate the impact of using transport reimbursement, intensified health education and SMS/telephonic tracing in increasing the uptake of voluntary medical male circumcision at this clinic.
Read the detailed description
This study will be a pragmatic, pre- and post-interventional quasi-experimental study combined with a prospective observational study design. The study will have pre-implementation and implementation phases and use a concurrent exploratory mixed method approach.
The study will evaluate the effect of multi-faceted intervention on the uptake of VMMC. The intervention includes use of transport reimbursement for men who will undergo VMMC, Intensified health education by VMMC champions and women and use of SMS/telephonic Tracing to remind clients of their VMMC appointment (the RITe intervention).
The intervention will be conducted in a sequential and incremental manner called implementation blocks. After collecting data from the standard of care period, the first implementation block will be for intensified health education. The next block will combine intensified health education with SMS/telephonic tracing. The last block will combine intensified health education with SMS/telephonic tracing and transport reimbursements. This approach will allow the investigator to compare the effectiveness of different combinations of the strategies in the intervention without necessarily randomizing participants. The sample size for each block is expected to be at least 80 uncircumcised men with STIs. The investigators anticipate that each block may last about 4-12 weeks (to allow the interventions to mature) with one week of no intervention between interventions as a wash out period. However, sample size may be higher if more uncircumcised men present within the minimum 4-week intervention period.
The study population will be men attending the Bwaila STI clinic in Lilongwe Malawi. The study will enroll a minimum of 320 men to depict an uptake rate of circumcision of about 28% (national average including traditional circumcision) among uncircumcised men. However, for each intervention to settle, the investigator will implement each intervention for at least 4 weeks.
Data on uptake of VMMC will be collected through a standardize data collection form in conjunction with routine data from the STI clinic electronic medical registry. Data on acceptability, appropriateness and feasibility will be collected through surveys, interviews and focus group discussions. The investigators will conduct about 280 surveys for acceptability, appropriateness and feasibility with men selected randomly through the implementation period (70 men per intervention block). About 20 in-depth interviews with healthcare workers equally divided by intervention block will be conducted to assess acceptability, appropriateness and feasibility. Finally, the investigators will conduct four focus group discussions with men through the study period to assess acceptability, appropriateness and feasibility of the RITe strategy.
- Conditions
- HIV Infections, Sexually Transmitted Infections
- Being tested
- Standard of care, Intensified Health Education, SMS/telephonic Tracing, Transportation Reimbursement
- Keywords
- Voluntary medical male circumcision, Men with sexually transmitted infections, Uptake, Acceptability, Feasibility
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Standard of care referral approach which is a brief health talk conducted once every morning by a VMMC mobilizer.
Intensified Health EducationBehavioural
More detailed health talk conducted during each group health talk session by the VMMC mobilizer and champions describing VMMC, its benefits and how to access the service and testimonies from men who have successfully undergone VMMC
SMS/telephonic TracingBehavioural
SMS tracing to remind participants of VMMC appointments
Transportation ReimbursementBehavioural
Transportation reimbursement to offset the cost of transportation for VMMC appointments
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Placebo comparator | Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services Receives: Other: Standard of care |
| Block 1 (intensified health education) | Experimental | Participants in this arm will be offered intensified health education Receives: Behavioral: Intensified Health Education |
| Block 2 (intensified health education and SMS/telephonic tracing) | Experimental | Participants in this arm will be offered intensified health education and SMS/telephonic tracing Receives: Behavioral: SMS/telephonic Tracing |
| Block 3 (intensified health education, SMS/telephonic tracing and transport reimbursement) | Experimental | Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement Receives: Behavioral: Transportation Reimbursement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC)
Each participant will be followed for 30 days to determine whether or not they receive circumcision. Number of participants who will undergo circumcision will be reported. The investigators will collect data on the number of participants offered VMMC and the number of participants who will undergo VMMC for each intervention block.
Measured: up to 30 days
Median Number of Days Taken for Male Clients to Undergo Circumcision From the Day Offered Circumcision at the STI Clinic (Time-to-circumcision)
The duration in days from when participants are offered VMMC to when the participants will undergo VMMC. The investigators will collect data on the number of days taken from the day circumcision is offered for each participant to undergo VMMC through the 30-day Follow-Up period.
Measured: up to 30 days
Secondary outcomes (10)
Percentage of Male Clients Who Reported the RITe Intervention As Acceptable
Acceptability measured quantitatively using the Acceptability of Intervention Measure (AIM) Likert scale surveys. The AIM Likert scale measures acceptability based on four constructs that assess whether an intervention is appealing, likable, welcome and approvable. The AIM score ranges from 6 - 80 1=completely disagree, 2=disagree, 3=Neutral, 4=agree and 5=completely agree. Higher scores indicate agreement with more acceptability items. The percentage is reported for those who strongly agree or agree assessed at Baseline and Follow-Up.
Measured: Baseline and Follow-Up, up to 30 days
Number of Male Clients With Perception That the RITe Intervention is Acceptable
Qualitative assessments for acceptability conducted using focus group discussions with uncircumcised men. Focus group discussions were conducted at Baseline and End of Study Follow Up to complement quantitative findings. Focus group discussions analyzed using thematic analysis and a summary of common themes presented.
Measured: Baseline, End of Study Follow Up (approximately Week 82)
Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible
Feasibility measured quantitatively using the Feasibility of Intervention Measure (FIM) Likert scale surveys. The FIM measures feasibility based on four constructs that assess whether an intervention is implementable, possible, resources, and difficult to use. Feasibility assessed among Healthcare Workers only as implementers of the intervention. Surveys for feasibility will be conducted for each intervention block during the implementation phase only. The FIM score range is 5 - 60 with 1=completely disagree, 2=disagree, 3=Neutral, 4=agree and 5=completely agree. Higher scores indicate agreement with more feasibility items. The percentage is reported for those who strongly agree or agree assessed at End of Study Follow Up.
Measured: End of Study Follow Up (approximately Week 82)
Number of Healthcare Workers With Perception That the RITe Intervention is Feasible
Qualitative assessments for intervention feasibility conducted using in-depth interviews with Healthcare Workers only at End of Study Follow Up to complement quantitative findings. The interviews were analyzed using thematic analysis and a summary of common themes presented.
Measured: End of Study Follow Up (approximately Week 82)
Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at Baseline
Qualitative assessments for acceptability conducted using in-depth interviews with Healthcare Workers at Baseline for the Standard of Care arm to complement quantitative findings. In-depth interviews were analyzed using thematic analysis and a summary of common themes presented.
Measured: Baseline
Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at End of Study Follow Up
Qualitative assessments for acceptability conducted using in-depth interviews with Healthcare Workers at End of Study Follow Up for the Block 3 arm to complement quantitative findings. In-depth interviews were analyzed using thematic analysis and a summary of common themes presented.
Measured: End of Study Follow Up (approximately Week 82)
Percentage of Male Clients Who Reported the RITe Intervention As Appropriate
Appropriateness measured quantitatively using the Intervention Appropriateness Measure (IAM) Likert scale surveys. The IAM Likert scale measures appropriateness based on four constructs that assess whether an intervention is embarrassing, culturally \& religiously suitable, and a good idea. Surveys for appropriateness were conducted at baseline and during implementation of each intervention block. The IAM score range is 5 - 85 from a scale with 1=completely disagree, 2=disagree, 3=Neutral, 4=agree and 5=completely agree. Higher scores indicate agreement with more appropriateness items. The percentage is reported for those who strongly agree or agree assessed at Baseline and Follow-Up.
Measured: Baseline and Follow-Up, up to 30 days
Number of Male Clients With Perception That the RITe Intervention is Appropriate
Qualitative assessments for appropriateness conducted using focus group discussions with uncircumcised men. Focus group discussions conducted at Baseline and End of Study Follow Up to complement quantitative findings. Focus group discussions were analyzed using thematic analysis and a summary of common themes presented.
Measured: Baseline, End of Study Follow Up (approximately Week 82)
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline
Qualitative assessments for appropriateness conducted using in-depth interviews with Healthcare Workers only. The interviews were conducted at Baseline to complement quantitative findings. The Interviews were analyzed using thematic analysis and a summary of common themes presented.
Measured: Baseline
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at End of Study Follow Up
Qualitative assessments for appropriateness conducted using in-depth interviews with Healthcare Workers only. The interviews were conducted at End of Study Follow Up to complement quantitative findings. The Interviews were analyzed using thematic analysis and a summary of common themes presented.
Measured: End of Study Follow Up (approximately Week 82)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Feb 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The intervention will be rolled-out in the implementation phase in a sequential and incremental manner called implementation blocks. Implementation blocks will be as follows: block 1: Intensified health education (I); block 2: Intensified health education and SMS/telephonic Tracing (IT) and finally, Block 3: Intensified health education, SMS/telephonic tracing and transport Reimbursement (RITe)
- Masking
- None (open label)
- Enrolment
- 2,242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Mitch Matoga, MD, MSc, Principal investigator, UNC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677374
- Sponsor's protocol ID
- 19-2559
- Other IDs
- D43TW010060
- Acronym
- VMMC-RITe
- Status last verified
- Jul 2023
- First submitted
- 15 Dec 2020
- Last updated
- 14 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matoga MM, Kudowa E, Chikuni J, Tsidya M, Tseka J, Ndalama B, Bonongwe N, Mathiya E, Jere E, Yatina D, Kamtambe B, Kapito M, Hosseinipour MC, Chasela CS, Jewett S. Acceptability, feasibility and appropriateness of intensified health education, SMS/phone tracing and transport reimbursement for uptake of voluntary medical male circumcision in a sexually transmitted infections clinic in Malawi: a mixed methods study. medRxiv [Preprint]. 2024 Apr 4:2024.03.27.24304985. doi: 10.1101/2024.03.27.24304985.
PubMed 38633812Matoga MM, Kudowa E, Ndalama B, Bonongwe N, Mathiya E, Jere E, Kamtambe B, Chagomerana M, Chasela C, Jewett S, Hosseinipour MC. Effectiveness of an intervention to increase uptake of voluntary medical male circumcision among men with sexually transmitted infections in Malawi: a preinterventional and postinterventional study. BMJ Open. 2023 Oct 3;13(10):e072855. doi: 10.1136/bmjopen-2023-072855.
PubMed 37788927Matoga MM, Hosseinipour MC, Jewett S, Chasela C. Uptake of voluntary medical male circumcision among men with sexually transmitted infections in Lilongwe, Malawi: a protocol for a pre-interventional and post-interventional study. BMJ Open. 2022 Jan 18;12(1):e057507. doi: 10.1136/bmjopen-2021-057507.
PubMed 35042709
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uptake of Voluntary Medical Male Circumcision Among Men Attending a Sexually Transmitted Infections Clinic in Lilongwe, Malawi
- ClinicalTrials.gov ID
- NCT04677374
- Acronym / sponsor ID
- VMMC-RITe / 19-2559
- Conditions
- HIV Infections, Sexually Transmitted Infections
- Keywords
- Voluntary medical male circumcision, Men with sexually transmitted infections, Uptake, Acceptability, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,242 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 14 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intervention includes provision of transport reimbursement for men who will undergo voluntary medical male circumcision (VMMC), intensified health education by a VMMC mobilizer and a male and female VMMC champion and use of a cell phone short messaging service (SMS) and/or telephonic tracing to remind clients of their VMMC appointment (the RITe intervention). The investigators will assess the uptake of VMMC, and acceptability, appropriateness and feasibility of the RITe intervention among uncircumcised men attending a Sexually Transmitted Infection (STI) clinic and health care workers.
This intervention was initially designed to include escorting men interested in circumcision from the STI clinic to a VMMC clinic co-located in the same facility. However, the VMMC clinic space was repurposed to a COVID-19 isolation unit therefore clinic escorts were excluded. In Lieu of clinic escorts, participants will be linked to the nearest health facility of choice where VMMC services are provided by the VMMC mobilizer.
The purpose of the study is to evaluate the impact of using transport reimbursement, intensified health education and SMS/telephonic tracing in increasing the uptake of voluntary medical male circumcision at this clinic.
Detailed description
This study will be a pragmatic, pre- and post-interventional quasi-experimental study combined with a prospective observational study design. The study will have pre-implementation and implementation phases and use a concurrent exploratory mixed method approach.
The study will evaluate the effect of multi-faceted intervention on the uptake of VMMC. The intervention includes use of transport reimbursement for men who will undergo VMMC, Intensified health education by VMMC champions and women and use of SMS/telephonic Tracing to remind clients of their VMMC appointment (the RITe intervention).
The intervention will be conducted in a sequential and incremental manner called implementation blocks. After collecting data from the standard of care period, the first implementation block will be for intensified health education. The next block will combine intensified health education with SMS/telephonic tracing. The last block will combine intensified health education with SMS/telephonic tracing and transport reimbursements. This approach will allow the investigator to compare the effectiveness of different combinations of the strategies in the intervention without necessarily randomizing participants. The sample size for each block is expected to be at least 80 uncircumcised men with STIs. The investigators anticipate that each block may last about 4-12 weeks (to allow the interventions to mature) with one week of no intervention between interventions as a wash out period. However, sample size may be higher if more uncircumcised men present within the minimum 4-week intervention period.
The study population will be men attending the Bwaila STI clinic in Lilongwe Malawi. The study will enroll a minimum of 320 men to depict an uptake rate of circumcision of about 28% (national average including traditional circumcision) among uncircumcised men. However, for each intervention to settle, the investigator will implement each intervention for at least 4 weeks.
Data on uptake of VMMC will be collected through a standardize data collection form in conjunction with routine data from the STI clinic electronic medical registry. Data on acceptability, appropriateness and feasibility will be collected through surveys, interviews and focus group discussions. The investigators will conduct about 280 surveys for acceptability, appropriateness and feasibility with men selected randomly through the implementation period (70 men per intervention block). About 20 in-depth interviews with healthcare workers equally divided by intervention block will be conducted to assess acceptability, appropriateness and feasibility. Finally, the investigators will conduct four focus group discussions with men through the study period to assess acceptability, appropriateness and feasibility of the RITe strategy.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The intervention will be rolled-out in the implementation phase in a sequential and incremental manner called implementation blocks. Implementation blocks will be as follows: block 1: Intensified health education (I); block 2: Intensified health education and SMS/telephonic Tracing (IT) and finally, Block 3: Intensified health education, SMS/telephonic tracing and transport Reimbursement (RITe)
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Placebo comparator | Other: Standard of careParticipants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services |
| Block 1 (intensified health education) | Experimental | Behavioral: Intensified Health EducationParticipants in this arm will be offered intensified health education |
| Block 2 (intensified health education and SMS/telephonic tracing) | Experimental | Behavioral: SMS/telephonic TracingParticipants in this arm will be offered intensified health education and SMS/telephonic tracing |
| Block 3 (intensified health education, SMS/telephonic tracing and transport reimbursement) | Experimental | Behavioral: Transportation ReimbursementParticipants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- 18 years or older
- Seeking STI care at the Bwaila STI clinic
- Not circumcised
- Healthcare workers at Bwaila STI and VMMC clinic
Key exclusion criteria (1 listed)
- < 18 years of age
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 |
|---|---|---|
| Standard of careStandard of care referral approach which is a brief health talk conducted once every morning by a VMMC mobilizer. | Other | Standard of care |
| Intensified Health EducationMore detailed health talk conducted during each group health talk session by the VMMC mobilizer and champions describing VMMC, its benefits and how to access the service and testimonies from men who have successfully undergone VMMC | Behavioural | Block 1 (intensified health education) |
| SMS/telephonic TracingSMS tracing to remind participants of VMMC appointments | Behavioural | Block 2 (intensified health education and SMS/telephonic tracing) |
| Transportation ReimbursementTransportation reimbursement to offset the cost of transportation for VMMC appointments | Behavioural | Block 3 (intensified health education, SMS/telephonic tracing and transport reimbursement) |
Primary outcome
Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC)
Time frame: up to 30 days
Each participant will be followed for 30 days to determine whether or not they receive circumcision. Number of participants who will undergo circumcision will be reported. The investigators will collect data on the number of participants offered VMMC and the number of participants who will undergo VMMC for each intervention block.
Median Number of Days Taken for Male Clients to Undergo Circumcision From the Day Offered Circumcision at the STI Clinic (Time-to-circumcision)
Time frame: up to 30 days
The duration in days from when participants are offered VMMC to when the participants will undergo VMMC. The investigators will collect data on the number of days taken from the day circumcision is offered for each participant to undergo VMMC through the 30-day Follow-Up period.
10 secondary outcomes
Percentage of Male Clients Who Reported the RITe Intervention As Acceptable
Time frame: Baseline and Follow-Up, up to 30 days
Number of Male Clients With Perception That the RITe Intervention is Acceptable
Time frame: Baseline, End of Study Follow Up (approximately Week 82)
Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible
Time frame: End of Study Follow Up (approximately Week 82)
Number of Healthcare Workers With Perception That the RITe Intervention is Feasible
Time frame: End of Study Follow Up (approximately Week 82)
Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at Baseline
Time frame: Baseline
Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at End of Study Follow Up
Time frame: End of Study Follow Up (approximately Week 82)
Percentage of Male Clients Who Reported the RITe Intervention As Appropriate
Time frame: Baseline and Follow-Up, up to 30 days
Number of Male Clients With Perception That the RITe Intervention is Appropriate
Time frame: Baseline, End of Study Follow Up (approximately Week 82)
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline
Time frame: Baseline
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at End of Study Follow Up
Time frame: End of Study Follow Up (approximately Week 82)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38633812Matoga MM, Kudowa E, Chikuni J, Tsidya M, Tseka J, Ndalama B, Bonongwe N, Mathiya E, Jere E, Yatina D, Kamtambe B, Kapito M, Hosseinipour MC, Chasela CS, Jewett S. Acceptability, feasibility and appropriateness of intensified health education, SMS/phone tracing and transport reimbursement for uptake of voluntary medical male circumcision in a sexually transmitted infections clinic in Malawi: a mixed methods study. medRxiv [Preprint]. 2024 Apr 4:2024.03.27.24304985. doi: 10.1101/2024.03.27.24304985.
- Derived from this study: PubMed 37788927Matoga MM, Kudowa E, Ndalama B, Bonongwe N, Mathiya E, Jere E, Kamtambe B, Chagomerana M, Chasela C, Jewett S, Hosseinipour MC. Effectiveness of an intervention to increase uptake of voluntary medical male circumcision among men with sexually transmitted infections in Malawi: a preinterventional and postinterventional study. BMJ Open. 2023 Oct 3;13(10):e072855. doi: 10.1136/bmjopen-2023-072855.
- Derived from this study: PubMed 35042709Matoga MM, Hosseinipour MC, Jewett S, Chasela C. Uptake of voluntary medical male circumcision among men with sexually transmitted infections in Lilongwe, Malawi: a protocol for a pre-interventional and post-interventional study. BMJ Open. 2022 Jan 18;12(1):e057507. doi: 10.1136/bmjopen-2021-057507.
- 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.
Mitch Matoga, MD, MSc principal investigator
UNC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensified Health Education, SMS/telephonic Tracing and Transportation Reimbursement in people with HIV Infections and Sexually Transmitted Infections, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
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 5 inclusion and 1 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 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. 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?
Yes. Results are posted in the registry (first posted 14 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Male Clients Who Will Undergo Circumcision (Uptake of VMMC) (time frame: up to 30 days). 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?
On the ClinicalTrials.gov record for NCT04677374, which also lists 3 linked publications.
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 14 Sep 2023.