HIV Infections, Sexually Transmitted Infections
Conditions
Keywords
Voluntary medical male circumcision, Men with sexually transmitted infections, Uptake, Acceptability, Feasibility
Brief 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 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.
Interventions
OTHERStandard of care
Standard of care referral approach which is a brief health talk conducted once every morning by a VMMC mobilizer.
BEHAVIORALIntensified 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
BEHAVIORALSMS/telephonic Tracing
SMS tracing to remind participants of VMMC appointments
BEHAVIORALTransportation Reimbursement
Transportation reimbursement to offset the cost of transportation for VMMC appointments
Sponsors
National Institutes of Health (NIH)
Fogarty International Center of the National Institute of Health
University of North Carolina, Chapel Hill
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Male * 18 years or older * Seeking STI care at the Bwaila STI clinic * Not circumcised * Healthcare workers at Bwaila STI and VMMC clinic
Exclusion criteria
* \< 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | End of Study Follow Up (approximately Week 82) | 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. |
| Number of Healthcare Workers With Perception That the RITe Intervention is Feasible | End of Study Follow Up (approximately Week 82) | 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. |
| Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at Baseline | 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. |
| Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at End of Study Follow Up | End of Study Follow Up (approximately Week 82) | 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. |
| Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Baseline and Follow-Up, up to 30 days | 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. |
| Number of Male Clients With Perception That the RITe Intervention is Appropriate | Baseline, End of Study Follow Up (approximately Week 82) | 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. |
| Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline | 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. |
| Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at End of Study Follow Up | End of Study Follow Up (approximately Week 82) | 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. |
| Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Baseline and Follow-Up, up to 30 days | 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. |
| Number of Male Clients With Perception That the RITe Intervention is Acceptable | Baseline, End of Study Follow Up (approximately Week 82) | 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. |
Countries
Malawi
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services | 514 |
| Block 1 (Intensified Health Education) Participants in this arm will be offered intensified health education | 731 |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) Participants in this arm will be offered intensified health education and SMS/telephonic tracing | 508 |
| 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 | 477 |
| Healthcare Workers Healthcare workers employed at the Sexually Transmitted Infection (STI) clinic who participated in the study | 12 |
| Total | 2,242 |
Baseline characteristics
| Characteristic | Healthcare Workers | Total | Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Block 1 (Intensified Health Education) | Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Standard of Care |
|---|---|---|---|---|---|---|
| Age, Continuous Healthcare Workers | 37 years STANDARD_DEVIATION 7 | 37 years STANDARD_DEVIATION 7 | — | — | — | — |
| Age, Continuous Male clients | — | 30 years STANDARD_DEVIATION 9 | 31 years STANDARD_DEVIATION 8 | 30 years STANDARD_DEVIATION 8 | 30 years STANDARD_DEVIATION 7 | 31 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 2242 Participants | 508 Participants | 731 Participants | 477 Participants | 514 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Healthcare Workers Years of Experience | 10 Years STANDARD_DEVIATION 6 | 10 Years STANDARD_DEVIATION 6 | — | — | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 2242 Participants | 508 Participants | 731 Participants | 477 Participants | 514 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Malawi | 12 Participants | 2242 Participants | 508 Participants | 731 Participants | 477 Participants | 514 Participants |
| Sex: Female, Male Female | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | — | 2230 Participants | 508 Participants | 731 Participants | 477 Participants | 514 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 514 | 0 / 731 | 0 / 508 | 0 / 477 |
| other Total, other adverse events | 0 / 514 | 0 / 731 | 0 / 508 | 0 / 477 |
| serious Total, serious adverse events | 0 / 514 | 0 / 731 | 0 / 508 | 0 / 477 |
Outcome results
Primary
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.
Time frame: up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | 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 |
| Block 1 (Intensified Health Education) | Median Number of Days Taken for Male Clients to Undergo Circumcision From the Day Offered Circumcision at the STI Clinic (Time-to-circumcision) | 6 days |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Median Number of Days Taken for Male Clients to Undergo Circumcision From the Day Offered Circumcision at the STI Clinic (Time-to-circumcision) | 3 days |
| Block 3 (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) | 9 days |
95% CI: [1.01, 4.93]
95% CI: [0.69, 4]
95% CI: [1, 5.36]
Primary
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.
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC) | 8 Participants |
| Block 1 (Intensified Health Education) | Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC) | 25 Participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC) | 13 Participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC) | 17 Participants |
p-value: 0.044Test of proportions
p-value: 0.259Test of proportions
p-value: 0.044Test of proportions
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at Baseline | Expressed Liking Intervention-Baseline | 9 Participants |
| Standard of Care | Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at Baseline | Expressed Intervention Approval-Baseline | 10 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Block 3 (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 |
| Block 3 (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 Intervention Approval-End of Study Follow Up | 7 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline | Expressed that Intervention is a Good Idea-Baseline | 10 Participants |
| Standard of Care | Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline | Intervention Aligned with Religion-Baseline | 8 Participants |
| Standard of Care | Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline | Intervention Aligned with Culture-Baseline | 8 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Block 3 (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 |
| Block 3 (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 | Intervention Aligned with Religion-End of Study Follow Up | 7 Participants |
| Block 3 (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 | Intervention Aligned with Culture-End of Study Follow Up | 7 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Block 3 (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 |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Number of Healthcare Workers With Perception That the RITe Intervention is Feasible | Concluded Intervention is 'Do-able' | 6 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Number of Male Clients With Perception That the RITe Intervention is Acceptable | Expressed Liking Intervention-Baseline | 14 Participants |
| Standard of Care | Number of Male Clients With Perception That the RITe Intervention is Acceptable | Expressed Liking Intervention-End of Study Follow Up | 0 Participants |
| Standard of Care | Number of Male Clients With Perception That the RITe Intervention is Acceptable | Expressed Intervention Approval-Baseline | 13 Participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Number of Male Clients With Perception That the RITe Intervention is Acceptable | Expressed Liking Intervention-End of Study Follow Up | 9 Participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Number of Male Clients With Perception That the RITe Intervention is Acceptable | Expressed Intervention Approval-End of Study Follow Up | 11 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Number of Male Clients With Perception That the RITe Intervention is Appropriate | Intervention Aligned with Religion-Baseline | 13 Participants |
| Standard of Care | Number of Male Clients With Perception That the RITe Intervention is Appropriate | Intervention Aligned with Culture-Baseline | 11 Participants |
| Standard of Care | Number of Male Clients With Perception That the RITe Intervention is Appropriate | Expressed that Intervention is a Good Idea-Baseline | 15 Participants |
| Block 3 (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-End of Study Follow Up | 11 Participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Number of Male Clients With Perception That the RITe Intervention is Appropriate | Intervention Aligned with Religion-End of Study Follow Up | 10 Participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Number of Male Clients With Perception That the RITe Intervention is Appropriate | Intervention Aligned with Culture-End of Study Follow Up | 11 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Block 1 (Intensified Health Education) | Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | Resources | 90 percentage of Healthcare Workers |
| Block 1 (Intensified Health Education) | Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | Difficult to use | 0 percentage of Healthcare Workers |
| Block 1 (Intensified Health Education) | Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | Implementable | 100 percentage of Healthcare Workers |
| Block 1 (Intensified Health Education) | Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | Possible | 90 percentage of Healthcare Workers |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | Implementable | 100 percentage of Healthcare Workers |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | Resources | 0 percentage of Healthcare Workers |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | Possible | 100 percentage of Healthcare Workers |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | Difficult to use | 0 percentage of Healthcare Workers |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | Resources | 40 percentage of Healthcare Workers |
| Block 3 (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 |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | Possible | 60 percentage of Healthcare Workers |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible | Implementable | 60 percentage of Healthcare Workers |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Approve-Follow-Up | 100 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Appealing-Follow-Up | 100 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Welcome-Baseline | 97 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Welcome-Follow-Up | 100 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Like-Baseline | 98.5 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Appealing-Baseline | 99 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Approve-Baseline | 97 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Like-Follow-Up | 100 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Approve-Baseline | 100 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Like-Baseline | 100 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Like-Follow-Up | 97.7 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Welcome-Baseline | 100 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Welcome-Follow-Up | 97.7 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Appealing-Baseline | 100 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Appealing-Follow-Up | 98 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Approve-Follow-Up | 100 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Appealing-Baseline | 97 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Like-Follow-Up | 96.7 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Approve-Follow-Up | 100 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Appealing-Follow-Up | 97 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Welcome-Baseline | 100 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Like-Baseline | 97 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Welcome-Follow-Up | 100 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Acceptable | Approve-Baseline | 100 percentage of participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Culturally suitable-Baseline | 62.3 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Embarrassing-Baseline | 26.1 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Good idea-Follow-Up | 100 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Religiously suitable-Follow-Up | 42.1 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Culturally suitable-Follow-Up | 42.1 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Embarrassing-Follow-Up | 31.6 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Good idea-Baseline | 98.6 percentage of participants |
| Block 1 (Intensified Health Education) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Religiously suitable-Baseline | 63.8 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Culturally suitable-Baseline | 27.9 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Culturally suitable-Follow-Up | 100 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Religiously suitable-Baseline | 98 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Religiously suitable-Follow-Up | 93 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Embarrassing-Baseline | 9.3 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Embarrassing-Follow-Up | 0 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Good idea-Baseline | 100 percentage of participants |
| Block 2 (Intensified Health Education and SMS/Telephonic Tracing) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Good idea-Follow-Up | 100 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Good idea-Baseline | 100 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Good idea-Follow-Up | 100 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Religiously suitable-Baseline | 11.8 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Embarrassing-Baseline | 2.9 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Religiously suitable-Follow-Up | 96.7 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Culturally suitable-Follow-Up | 100 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Culturally suitable-Baseline | 11.8 percentage of participants |
| Block 3 (Intensified Health Education, SMS/Telephonic Tracing and Transport Reimbursement) | Percentage of Male Clients Who Reported the RITe Intervention As Appropriate | Embarrassing-Follow-Up | 0 percentage of participants |