Trial Outcomes & Findings for Uptake of Medical Male Circumcision Among Men With Sexually Transmitted Infections (NCT NCT04677374)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2242 participants

Primary outcome timeframe

up to 30 days

Results posted on

2023-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services Standard of care: Standard of care referral approach which is a brief health talk conducted once every morning by a VMMC mobilizer.	Block 1 (Intensified Health Education) Participants in this arm will be offered intensified health education Intensified Health Education: 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	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) Participants in this arm will be offered intensified health education and short messaging service (SMS)/telephonic tracing SMS/telephonic Tracing: SMS tracing to remind participants of VMMC appointments	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement Transportation Reimbursement: Transportation reimbursement to offset the cost of transportation for VMMC appointments	Healthcare Workers Healthcare workers employed at the Sexually Transmitted Infection (STI) clinic who participated in the study
Overall Study STARTED	514	731	508	477	12
Overall Study COMPLETED	514	731	508	477	12
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data reported separately for Male clients and Healthcare Workers.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=514 Participants Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) n=731 Participants Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) n=508 Participants Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) n=477 Participants Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement	Healthcare Workers n=12 Participants Healthcare workers employed at the Sexually Transmitted Infection (STI) clinic who participated in the study	Total n=2242 Participants Total of all reporting groups
Age, Continuous Male clients	31 years STANDARD_DEVIATION 9 • n=514 Participants • Data reported separately for Male clients and Healthcare Workers.	30 years STANDARD_DEVIATION 8 • n=731 Participants • Data reported separately for Male clients and Healthcare Workers.	31 years STANDARD_DEVIATION 8 • n=508 Participants • Data reported separately for Male clients and Healthcare Workers.	30 years STANDARD_DEVIATION 7 • n=477 Participants • Data reported separately for Male clients and Healthcare Workers.	—	30 years STANDARD_DEVIATION 9 • n=2230 Participants • Data reported separately for Male clients and Healthcare Workers.
Age, Continuous Healthcare Workers	—	—	—	—	37 years STANDARD_DEVIATION 7 • n=12 Participants • Data reported separately for Male clients and Healthcare Workers.	37 years STANDARD_DEVIATION 7 • n=12 Participants • Data reported separately for Male clients and Healthcare Workers.
Sex: Female, Male Female	0 Participants n=514 Participants • Data not collected for Healthcare Workers.	0 Participants n=731 Participants • Data not collected for Healthcare Workers.	0 Participants n=508 Participants • Data not collected for Healthcare Workers.	0 Participants n=477 Participants • Data not collected for Healthcare Workers.	—	0 Participants n=2230 Participants • Data not collected for Healthcare Workers.
Sex: Female, Male Male	514 Participants n=514 Participants • Data not collected for Healthcare Workers.	731 Participants n=731 Participants • Data not collected for Healthcare Workers.	508 Participants n=508 Participants • Data not collected for Healthcare Workers.	477 Participants n=477 Participants • Data not collected for Healthcare Workers.	—	2230 Participants n=2230 Participants • Data not collected for Healthcare Workers.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=514 Participants	0 Participants n=731 Participants	0 Participants n=508 Participants	0 Participants n=477 Participants	0 Participants n=12 Participants	0 Participants n=2242 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	514 Participants n=514 Participants	731 Participants n=731 Participants	508 Participants n=508 Participants	477 Participants n=477 Participants	12 Participants n=12 Participants	2242 Participants n=2242 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=514 Participants	0 Participants n=731 Participants	0 Participants n=508 Participants	0 Participants n=477 Participants	0 Participants n=12 Participants	0 Participants n=2242 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=514 Participants	0 Participants n=731 Participants	0 Participants n=508 Participants	0 Participants n=477 Participants	0 Participants n=12 Participants	0 Participants n=2242 Participants
Race (NIH/OMB) Asian	0 Participants n=514 Participants	0 Participants n=731 Participants	0 Participants n=508 Participants	0 Participants n=477 Participants	0 Participants n=12 Participants	0 Participants n=2242 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=514 Participants	0 Participants n=731 Participants	0 Participants n=508 Participants	0 Participants n=477 Participants	0 Participants n=12 Participants	0 Participants n=2242 Participants
Race (NIH/OMB) Black or African American	514 Participants n=514 Participants	731 Participants n=731 Participants	508 Participants n=508 Participants	477 Participants n=477 Participants	12 Participants n=12 Participants	2242 Participants n=2242 Participants
Race (NIH/OMB) White	0 Participants n=514 Participants	0 Participants n=731 Participants	0 Participants n=508 Participants	0 Participants n=477 Participants	0 Participants n=12 Participants	0 Participants n=2242 Participants
Race (NIH/OMB) More than one race	0 Participants n=514 Participants	0 Participants n=731 Participants	0 Participants n=508 Participants	0 Participants n=477 Participants	0 Participants n=12 Participants	0 Participants n=2242 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=514 Participants	0 Participants n=731 Participants	0 Participants n=508 Participants	0 Participants n=477 Participants	0 Participants n=12 Participants	0 Participants n=2242 Participants
Region of Enrollment Malawi	514 Participants n=514 Participants	731 Participants n=731 Participants	508 Participants n=508 Participants	477 Participants n=477 Participants	12 Participants n=12 Participants	2242 Participants n=2242 Participants
Healthcare Workers Years of Experience	—	—	—	—	10 Years STANDARD_DEVIATION 6 • n=12 Participants • Data not collected for Male clients.	10 Years STANDARD_DEVIATION 6 • n=12 Participants • Data not collected for Male clients.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard of Care n=514 Participants Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) n=731 Participants Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) n=508 Participants Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) n=477 Participants Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC)	8 Participants	25 Participants	13 Participants	17 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard of Care n=8 Participants Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) n=25 Participants Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) n=13 Participants Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) n=17 Participants Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Median Number of Days Taken for Male Clients to Undergo Circumcision From the Day Offered Circumcision at the STI Clinic (Time-to-circumcision)	15 days Interval 9.0 to 18.0	6 days Interval 1.0 to 9.0	3 days Interval 0.0 to 6.0	9 days Interval 0.0 to 14.0

SECONDARY outcome

Timeframe: Baseline and Follow-Up, up to 30 days

Population: Participants who received Standard of Care did not participate in the survey. Survey participation was optional for participants in Blocks 1, 2, and 3 and data are reported for all of those who elected to participate. Follow-Up data are missing for some participants who were unavailable.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) n=69 Participants Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) n=43 Participants Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) n=34 Participants Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Percentage of Male Clients Who Reported the RITe Intervention As Acceptable Approve-Baseline	—	97 percentage of participants	100 percentage of participants	100 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Acceptable Approve-Follow-Up	—	100 percentage of participants	100 percentage of participants	100 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Acceptable Like-Baseline	—	98.5 percentage of participants	100 percentage of participants	97 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Acceptable Like-Follow-Up	—	100 percentage of participants	97.7 percentage of participants	96.7 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Acceptable Welcome-Baseline	—	97 percentage of participants	100 percentage of participants	100 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Acceptable Welcome-Follow-Up	—	100 percentage of participants	97.7 percentage of participants	100 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Acceptable Appealing-Baseline	—	99 percentage of participants	100 percentage of participants	97 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Acceptable Appealing-Follow-Up	—	100 percentage of participants	98 percentage of participants	97 percentage of participants

SECONDARY outcome

Timeframe: Baseline, End of Study Follow Up (approximately Week 82)

Population: Baseline focus group discussions were only conducted in the Standard of Care arm and End of Study Follow Up focus group discussions were conducted only in the Block 3 arm. Focus group discussion participation was limited in number to allow for discussion moderation. Data are reported for all participants who engaged in the discussions.

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.

Outcome measures

Outcome measures
Measure	Standard of Care n=16 Participants Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) n=11 Participants Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Number of Male Clients With Perception That the RITe Intervention is Acceptable Expressed Liking Intervention-Baseline	14 Participants	—	—	—
Number of Male Clients With Perception That the RITe Intervention is Acceptable Expressed Liking Intervention-End of Study Follow Up	0 Participants	—	—	9 Participants
Number of Male Clients With Perception That the RITe Intervention is Acceptable Expressed Intervention Approval-Baseline	13 Participants	—	—	—
Number of Male Clients With Perception That the RITe Intervention is Acceptable Expressed Intervention Approval-End of Study Follow Up	—	—	—	11 Participants

SECONDARY outcome

Timeframe: End of Study Follow Up (approximately Week 82)

Population: Data are reported only for Healthcare Workers as this outcome does not apply to Male clients. The Standard of Care arm was not assessed since this outcome focused on the study intervention. Of the 12 participating Healthcare Workers, only 7 were available at the End of Study Follow Up to rate each intervention.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) n=7 Participants Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) n=7 Participants Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) n=7 Participants Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible Difficult to use	—	0 percentage of Healthcare Workers	0 percentage of Healthcare Workers	0 percentage of Healthcare Workers
Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible Implementable	—	100 percentage of Healthcare Workers	100 percentage of Healthcare Workers	60 percentage of Healthcare Workers
Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible Possible	—	90 percentage of Healthcare Workers	100 percentage of Healthcare Workers	60 percentage of Healthcare Workers
Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible Resources	—	90 percentage of Healthcare Workers	0 percentage of Healthcare Workers	40 percentage of Healthcare Workers

SECONDARY outcome

Timeframe: End of Study Follow Up (approximately Week 82)

Population: Data are reported only for Healthcare Workers as this outcome does not apply to Male clients. Of the 12 participating Healthcare Workers, only 7 were available for the in-depth interviews at End of Study Follow Up.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) n=7 Participants Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Number of Healthcare Workers With Perception That the RITe Intervention is Feasible Concluded Intervention Successfully Implemented	—	—	—	7 Participants
Number of Healthcare Workers With Perception That the RITe Intervention is Feasible Concluded Intervention is 'Do-able'	—	—	—	6 Participants

SECONDARY outcome

Timeframe: Baseline

Population: In-depth interview participation was limited in number to allow for discussion moderation. Data are reported for all Healthcare Workers who engaged in the discussions. Of the 12 participating Healthcare Workers, only 10 were available for the in-depth interviews 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.

Outcome measures

Outcome measures
Measure	Standard of Care n=10 Participants Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at Baseline Expressed Liking Intervention-Baseline	9 Participants	—	—	—
Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at Baseline Expressed Intervention Approval-Baseline	10 Participants	—	—	—

SECONDARY outcome

Timeframe: End of Study Follow Up (approximately Week 82)

Population: In-depth interview participation was limited in number to allow for discussion moderation. Data are reported for all healthcare workers who engaged in the discussions. Of the 12 participating Healthcare workers, only 7 were available 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.

Outcome measures

Outcome measures
Measure	Standard of Care Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) n=7 Participants Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at End of Study Follow Up Expressed Liking Intervention-End of Study Follow Up	—	—	—	7 Participants
Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at End of Study Follow Up Expressed Intervention Approval-End of Study Follow Up	—	—	—	7 Participants

SECONDARY outcome

Timeframe: Baseline and Follow-Up, up to 30 days

Population: Participants who received Standard of Care did not participate in the survey. Survey participation was optional and data are reported for all of those who elected to participate. Follow-Up data are missing for some participants who were unavailable.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) n=69 Participants Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) n=43 Participants Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) n=34 Participants Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Percentage of Male Clients Who Reported the RITe Intervention As Appropriate Culturally suitable-Baseline	—	62.3 percentage of participants	27.9 percentage of participants	11.8 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Appropriate Culturally suitable-Follow-Up	—	42.1 percentage of participants	100 percentage of participants	100 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Appropriate Embarrassing-Baseline	—	26.1 percentage of participants	9.3 percentage of participants	2.9 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Appropriate Embarrassing-Follow-Up	—	31.6 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Appropriate Good idea-Baseline	—	98.6 percentage of participants	100 percentage of participants	100 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Appropriate Good idea-Follow-Up	—	100 percentage of participants	100 percentage of participants	100 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Appropriate Religiously suitable-Baseline	—	63.8 percentage of participants	98 percentage of participants	11.8 percentage of participants
Percentage of Male Clients Who Reported the RITe Intervention As Appropriate Religiously suitable-Follow-Up	—	42.1 percentage of participants	93 percentage of participants	96.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, End of Study Follow Up (approximately Week 82)

Population: Baseline focus group discussions were only conducted in the Standard of Care arm and End of Study Follow Up focus group discussions were conducted only in the Block 3 arm. Focus group discussion participation was limited in number to allow for discussion moderation. Data are reported for all participants who engaged in the discussions.

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.

Outcome measures

Outcome measures
Measure	Standard of Care n=16 Participants Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) n=11 Participants Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Number of Male Clients With Perception That the RITe Intervention is Appropriate Expressed that Intervention is a Good Idea-Baseline	15 Participants	—	—	—
Number of Male Clients With Perception That the RITe Intervention is Appropriate Expressed that Intervention is a Good Idea-End of Study Follow Up	—	—	—	11 Participants
Number of Male Clients With Perception That the RITe Intervention is Appropriate Intervention Aligned with Religion-Baseline	13 Participants	—	—	—
Number of Male Clients With Perception That the RITe Intervention is Appropriate Intervention Aligned with Religion-End of Study Follow Up	—	—	—	10 Participants
Number of Male Clients With Perception That the RITe Intervention is Appropriate Intervention Aligned with Culture-Baseline	11 Participants	—	—	—
Number of Male Clients With Perception That the RITe Intervention is Appropriate Intervention Aligned with Culture-End of Study Follow Up	—	—	—	11 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Baseline in-depth interviews were only conducted in the Standard of Care arm. In-depth interview participation was limited to Healthcare Workers who accepted to participate and who engaged in the discussions. Of the 12 participating Healthcare Workers, only 10 were available 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.

Outcome measures

Outcome measures
Measure	Standard of Care n=10 Participants Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline Expressed that Intervention is a Good Idea-Baseline	10 Participants	—	—	—
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline Intervention Aligned with Religion-Baseline	8 Participants	—	—	—
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline Intervention Aligned with Culture-Baseline	8 Participants	—	—	—

SECONDARY outcome

Timeframe: End of Study Follow Up (approximately Week 82)

Population: These in-depth interviews were conducted only in the Block 3 arm with participation limited to Healthcare Workers who accepted to participate. Data are reported for those who engaged in the discussions. Of the 12 participating Healthcare Workers, only 7 were available.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Block 1 (Intensified Health Education) Participants in this arm will be offered intensified health education	Block 2 (Intensified Health Education and SMS/Telephonic Tracing) Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) n=7 Participants Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at End of Study Follow Up Expressed that Intervention is a Good Idea-End of Study Follow Up	—	—	—	7 Participants
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at End of Study Follow Up Intervention Aligned with Religion-End of Study Follow Up	—	—	—	7 Participants
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at End of Study Follow Up Intervention Aligned with Culture-End of Study Follow Up	—	—	—	7 Participants

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Block 1 (Intensified Health Education)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Block 2 (Intensified Health Education and SMS/Telephonic Tracing)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mitch Matoga, MD, MS

University of North Carolina at Chapel Hill

Phone: 00265 1 755056

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place