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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG034420-10 | U.S. NIH Grant/Contract | View source | |
| R01AI114310 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institute on Aging (NIA) | NIH |
| Southern Medical University, China | OTHER |
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This is a randomized controlled trial which will evaluate dual gonorrhea/chlamydia test uptake and other outcomes in men who have sex with men (MSM) in three trial arms - 1) a pay-it-forward testing arm, 2) a pay-what-you-want testing arm, and 3) standard of care arm.
At both of the program sites, MSM partaking in HIV and syphilis testing will be offered dual gonorrhea/chlamydia testing. First, all men will be provided a brief (5 minute) introduction to gonorrhea and chlamydia testing using a pamphlet. Program organizers will then explain the pay-it-forward program to each man separately. Briefly, men will be told that the hospital list price of gonorrhea and chlamydia testing was 150 RMB ($24 USD), but previous men attending the clinic had donated money to cover the cost of his test. Thus, each man could receive a free gonorrhea and chlamydia test, then decide whether to donate money (pay-it-forward) for future men to receive the same option. Men will be assured that donating is completely optional and advised to pay any amount that is feasible for them. Each man's gonorrhea and chlamydia test fees will be covered by a combination of the initial funding pool from the program organizers and the donations from previous participants. Men will also be shown a postcard with a message written by a previous pay-it-forward contributor. Messages will contain information encouraging men to be tested/slogans to promote sexual health and testing (i.e. taking ownership of their health). They will be told that they could also write a postcard message for a future participant.
Men will then decide whether or not to receive combined urine gonorrhea/chlamydia testing. Program organizers will inform participants of their test results via WeChat. Patients with positive test results will be counseled and directed to the WeChat page of designated hospitals where they could make an appointment to receive treatment and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pay-it-forward | Experimental | First, participants will be provided a brief introduction to gonorrhea and chlamydia testing. Then, participants will be offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option. |
|
| Pay-what-you-want | Experimental | First, participants will be provided a brief introduction to gonorrhea and chlamydia testing. Then, participants will be offered gonorrhoea and chlamydia testing and told that they can decide and pay any desired amount after receiving the test. |
|
| Standard of care | No Intervention | First, participants will be provided a brief introduction to gonorrhea and chlamydia testing. Then, participants will be offered gonorrhoea and chlamydia testing at the standard patient price. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pay-it-forward | Other | Participants will be offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received the Dual Gonorrhea/Chlamydia Testing | Dual gonorrhea/chlamydia test uptake as assessed by administrative records in each arm. | During enrollment visit, an approximate total of 1.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Tested Positive for Gonorrhea | The number of men who tested positive for gonorrhea through this study. Samples were collected either from urine or rectum. | During enrollment visit, an approximate total of 1.5 hours |
| Number of Participants Tested Positive for Chlamydia |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph D Tucker, MD, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Medical University | Guangzhou | Guangdong | China | |||
| Zhitong Guangzhou LGBT Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30587296 | Background | Li KT, Tang W, Wu D, Huang W, Wu F, Lee A, Feng H, Pan SW, Han L, Mak V, Yang L, Tucker JD. Pay-it-forward strategy to enhance uptake of dual gonorrhea and chlamydia testing among men who have sex with men in China: a pragmatic, quasi-experimental study. Lancet Infect Dis. 2019 Jan;19(1):76-82. doi: 10.1016/S1473-3099(18)30556-5. | |
| 28406270 | Background | Zhang TP, Liu C, Han L, Tang W, Mao J, Wong T, Zhang Y, Tang S, Yang B, Wei C, Tucker JD. Community engagement in sexual health and uptake of HIV testing and syphilis testing among MSM in China: a cross-sectional online survey. J Int AIDS Soc. 2017 Apr 3;20(1):21372. doi: 10.7448/IAS.20.01.21372. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pay-it-forward | First, participants were provided a brief introduction to gonorrhea and chlamydia testing. Then, participants were offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option. Pay-it-forward: Participants were offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option. |
| FG001 | Pay-what-you-want | First, participants were provided a brief introduction to gonorrhea and chlamydia testing. Then, participants were offered gonorrhoea and chlamydia testing and told that they could decide and pay any desired amount after receiving the test. Pay-what-you-want: Participants were offered gonorrhoea and chlamydia testing and told that they could decide and pay any desired amount after receiving the test. |
| FG002 | Standard of Care | First, participants were provided a brief introduction to gonorrhea and chlamydia testing. Then, participants were offered gonorrhoea and chlamydia testing at the standard patient price. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Each arm had ten clusters of participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pay-it-forward | Men in pay-it-forward were told that the standard price of the gonorrhea and chlamydia testing was 150RMB ($22US), and that previous participants who cared about them donated toward testing fees. Thus, men in the pay-it-forward arm received a free test, and then decided whether, and if so how much to donate toward future testing for others. Participants were shown postcards and told that testing and donating were voluntary. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 3 in pay-it-forward arm, 7 in pay-what-you-want arm, and 3 in standard-of-care arm did not complete or submit their survey questionnaires. Hence, demographic and behavioral information is lacking for them. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Received the Dual Gonorrhea/Chlamydia Testing | Dual gonorrhea/chlamydia test uptake as assessed by administrative records in each arm. | Posted | Count of Participants | Participants | During enrollment visit, an approximate total of 1.5 hours |
|
Time frame was during one study visit on the day of participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pay-it-forward | Men in pay-it-forward were told that the standard price of the gonorrhea and chlamydia testing was 150RMB ($22US), and that previous participants who cared about them donated toward testing fees. Thus, men in the pay-it-forward arm received a free test, and then decided whether, and if so how much to donate toward future testing for others. Participants were shown postcards and told that testing and donating were voluntary. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Weiming Tang | University of North Carolina, Project-China | +86-15920567132 | weiming_tang@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2019 | Dec 27, 2019 | Prot_SAP_000.pdf |
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| London School of Hygiene and Tropical Medicine |
| OTHER |
| Social Entrepreneurship to Spur Health | OTHER |
| Yale University | OTHER |
3-arm superiority randomized controlled
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| Pay-what-you-want | Other | Participants will be offered gonorrhoea and chlamydia testing and told that they can decide and pay any desired amount after receiving the test. |
|
The is the number of men who tested positive for chlamydia through this study |
| During enrollment visit, an approximate total of 1.5 hours |
| Cost Per Test | Cost per test, defined as the cost associated with respective interventions (development, start-up, implementation, intervention) per individual who reported testing for gonorrhea and chlamydia following the intervention; economic test and financial cost are reported separately. | During enrollment visit, an approximate total of 1.5 hours |
| Cost Per Diagnosis | Cost per diagnosis, defined as the cost associated with respective interventions (development, start-up, implementation, intervention) per individual who tested positive for gonorrhea and/or chlamydia following the intervention. Cost using economic cost and financial cost were respectively reported. | During enrollment visit, an approximate total of 1.5 hours |
| Number of Participants Reporting Community Engagement Activities | Number of participants who reported yes/no to specific questions on the awareness of and/or participation in MSM-related causes, organizations, or community events | During enrollment visit, an approximate total of 1.5 hours |
| Community Connectedness Scale Scores | Community connectedness scales include six statements and Likert scale response ranging from 1= Strongly disagree, 2= Agree, 3= Disagree, and 4= Strongly agree. For each scale item, the range spans across 1 to 4, with higher score indicating more agreement with the statement and potentially higher community connectedness. | During enrollment visit, an approximate total of 1.5 hours |
| Social Cohesion Scale Scores | Social cohesion is a scale made of seven statements and Likert response to them ranging from 1= strongly disagree, 2 = disagree, 3 = agree, and 4= strongly agree. Those questions asked about the feelings of being able to depend on a larger MSM community (i.e., tongzhi circle, gay online networks or groups). For each item, the range spans across 1 to 4. For items 1 to 5, the higher score, the more agreement with the statement and potentially the higher social cohesion. Item 6 and 7 are reversely scored, meaning that the higher the score, the lower social cohesion potentially. | During enrollment visit, an approximate total of 1.5 hours |
| Guangzhou |
| Guangdong |
| China |
| BlueD Danlan Happy Testing Office | Beijing | China |
| 32530426 | Derived | Yang F, Zhang TP, Tang W, Ong JJ, Alexander M, Forastiere L, Kumar N, Li KT, Zou F, Yang L, Mi G, Wang Y, Huang W, Lee A, Zhu W, Luo D, Vickerman P, Wu D, Yang B, Christakis NA, Tucker JD. Pay-it-forward gonorrhoea and chlamydia testing among men who have sex with men in China: a randomised controlled trial. Lancet Infect Dis. 2020 Aug;20(8):976-982. doi: 10.1016/S1473-3099(20)30172-9. Epub 2020 Apr 28. |
| 31426869 | Derived | Zhang TP, Yang F, Tang W, Alexander M, Forastiere L, Kumar N, Li K, Zou F, Yang L, Mi G, Wang Y, Huang W, Lee A, Zhu W, Vickerman P, Wu D, Yang B, Christakis NA, Tucker JD. Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men in China: a study protocol for a three-arm cluster randomized controlled trial. Infect Dis Poverty. 2019 Aug 16;8(1):76. doi: 10.1186/s40249-019-0581-1. |
| BG001 | Pay-what-you-want | After being introduced to the testing and the study, men in the pay-what-you-want arm were told that the standard price of gonorrhea and chlamydia testing was 150RMB ($22US), and that they would receive free testing and then decide the amount that they would like to pay for their own test. |
| BG002 | Standard-of-care | Men in the standard of care arm received the same introduction to gonorrhea and chlamydia testing as the men in the other two arms. They were then told that the standard price of gonorrhea and chlamydia testing was 150RMB (US$22) and they had to pay the full amount for the their testing. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | 3 in pay-it-forward arm, 7 in pay-what-you-want arm, and 3 in standard-of-care arm did not complete or submit their survey questionnaires. Hence, demographic and behavioral information is lacking for them. | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital status | 3 in pay-it-forward arm, 7 in pay-what-you-want arm, and 3 in standard-of-care arm did not complete or submit their survey questionnaires. Hence, demographic and behavioral information is lacking for them. | Count of Participants | Participants |
|
| Highest education completed | 3 in pay-it-forward arm, 7 in pay-what-you-want arm, and 3 in standard-of-care arm did not complete or submit their survey questionnaires. Hence, demographic and behavioral information is lacking for them. | Count of Participants | Participants |
|
| Annual income (USD) | 3 in pay-it-forward arm, 7 in pay-what-you-want arm, and 3 in standard-of-care arm did not complete or submit their survey questionnaires. Hence, demographic and behavioral information is lacking for them. | Count of Participants | Participants |
|
| Number of sex partners in the past three months, Categorical | 3 in pay-it-forward arm, 7 in pay-what-you-want arm, and 3 in standard-of-care arm did not complete or submit their survey questionnaires. Hence, demographic and behavioral information is lacking for them. Two additional participants in pay-it-forward, two in pay-what-you-want, and six in standard-of-care did not respond to this question. | Count of Participants | Participants |
|
| Had anal sex in the past three months | 3 in pay-it-forward arm, 7 in pay-what-you-want arm, and 3 in standard-of-care arm did not complete or submit their survey questionnaires. Hence, demographic and behavioral information is lacking for them. One additional person in standard-of-care did not respond to this specific survey question. | Count of Participants | Participants |
|
| Condom use frequency during anal sex in the past three months | Only participants who reported having had anal sex in the past three months were asked this question about condom use during anal sex. | Count of Participants | Participants |
|
| HIV testing frequency in the past two years | 3 in pay-it-forward arm, 7 in pay-what-you-want arm, and 3 in standard-of-care arm did not complete or submit their survey questionnaires. Hence, demographic and behavioral information is lacking for them. One additional participant in the standard-of-care arm did not respond to this specific survey question. | Count of Participants | Participants |
|
After being introduced to the testing and the study, men in the pay-what-you-want arm were told that the standard price of gonorrhea and chlamydia testing was 150RMB ($22US), and that they would receive free testing and then decide the amount that they would like to pay for their own test. |
| OG002 | Standard-of-care | Men in the standard of care arm received the same introduction to gonorrhea and chlamydia testing as the men in the other two arms. They were then told that the standard price of gonorrhea and chlamydia testing was 150RMB (US$22) and they had to pay the full amount for the their testing. |
|
|
| Secondary | Number of Participants Tested Positive for Gonorrhea | The number of men who tested positive for gonorrhea through this study. Samples were collected either from urine or rectum. | Overall Number of Participants Analyzed include the participants who received the Dual Gonorrhea/Chlamydia Testing | Posted | Count of Participants | Participants | During enrollment visit, an approximate total of 1.5 hours |
|
|
|
| Secondary | Number of Participants Tested Positive for Chlamydia | The is the number of men who tested positive for chlamydia through this study | Overall Number of Participants Analyzed include the participants who received the Dual Gonorrhea/Chlamydia Testing | Posted | Count of Participants | Participants | During enrollment visit, an approximate total of 1.5 hours |
|
|
|
| Secondary | Cost Per Test | Cost per test, defined as the cost associated with respective interventions (development, start-up, implementation, intervention) per individual who reported testing for gonorrhea and chlamydia following the intervention; economic test and financial cost are reported separately. | Posted | Mean | Standard Deviation | USD | During enrollment visit, an approximate total of 1.5 hours |
|
|
|
| Secondary | Cost Per Diagnosis | Cost per diagnosis, defined as the cost associated with respective interventions (development, start-up, implementation, intervention) per individual who tested positive for gonorrhea and/or chlamydia following the intervention. Cost using economic cost and financial cost were respectively reported. | Posted | Mean | Standard Error | USD | During enrollment visit, an approximate total of 1.5 hours |
|
|
|
| Secondary | Number of Participants Reporting Community Engagement Activities | Number of participants who reported yes/no to specific questions on the awareness of and/or participation in MSM-related causes, organizations, or community events | Those are participants who filled out this questionnaire among those who participated in the study. In total, 3 participants did not respond in Pay-it-for-ward, 7 in Pay-what-you-want, and 3 in Standard of Care. | Posted | Count of Participants | Participants | During enrollment visit, an approximate total of 1.5 hours |
|
|
|
| Secondary | Community Connectedness Scale Scores | Community connectedness scales include six statements and Likert scale response ranging from 1= Strongly disagree, 2= Agree, 3= Disagree, and 4= Strongly agree. For each scale item, the range spans across 1 to 4, with higher score indicating more agreement with the statement and potentially higher community connectedness. | Some participants declined to answer certain questions. Hence, the number analyzed in some rows is different from the overall number analyzed. | Posted | Mean | Standard Deviation | score on a scale | During enrollment visit, an approximate total of 1.5 hours |
|
|
|
| Secondary | Social Cohesion Scale Scores | Social cohesion is a scale made of seven statements and Likert response to them ranging from 1= strongly disagree, 2 = disagree, 3 = agree, and 4= strongly agree. Those questions asked about the feelings of being able to depend on a larger MSM community (i.e., tongzhi circle, gay online networks or groups). For each item, the range spans across 1 to 4. For items 1 to 5, the higher score, the more agreement with the statement and potentially the higher social cohesion. Item 6 and 7 are reversely scored, meaning that the higher the score, the lower social cohesion potentially. | Some participants chose to decline certain questions, which resulted in numbers analyzed in some rows being different from the overall number analyzed. | Posted | Mean | Standard Deviation | score on a scale | During enrollment visit, an approximate total of 1.5 hours |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Pay-what-you-want | After being introduced to the testing and the study, men in the pay-what-you-want arm were told that the standard price of gonorrhea and chlamydia testing was 150RMB ($22US), and that they would receive free testing and then decide the amount that they would like to pay for their own test. | 0 | 100 | 0 | 100 | 0 | 100 |
| EG002 | Standard-of-care | Men in the standard of care arm received the same introduction to gonorrhea and chlamydia testing as the men in the other two arms. They were then told that the standard price of gonorrhea and chlamydia testing was 150RMB (US$22) and they had to pay the full amount for the their testing. | 0 | 100 | 0 | 100 | 0 | 100 |
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| >30 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Other (engaged, married, divorced or separated) |
|
| High/vocational school |
|
| College or above |
|
| 2,681- 5,360 |
|
| 5,361- 8,934 |
|
| 8,935- 14,294 |
|
| >14,294 |
|
| Multiple |
|
| No |
|
| Sometimes |
|
| Often |
|
| Always |
|
| < once every two years |
|
| Once a year |
|
| Every six months |
|
| Every three months |
|
| Monthly |
|
|
|
| No |
|
| Are you aware of any ongoing MSM-related community |
|
|
| Have you ever encouraged someone to use MSM-relate |
|
|
| Have you ever attended MSM-related community event |
|
|
| Have you ever donated to MSM-related causes, event |
|
|
| Have you ever volunteered for MSM-related causes |
|
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| Participating in MSM community is a positive thing |
|
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| You are proud of the MSM community |
|
|
| Important for you to advocate for the community |
|
|
| If you all work together, problems will be solved |
|
|
| Any problems faced by the MSM are also yours |
|
|
| You can count on other MSM to talk about problems |
|
|
| You can count on other MSM if you need a place |
|
|
| MSM you socialize with is an integrated group |
|
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| You can trust the majority of the MSM you know. |
|
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| MSM in your group only worry about themselves |
|
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| MSM you socialize with are always arguing |
|
|