Gonorrhea Male Clinical Trial
Official title:
Pay-it-forward Gonorrhea and Chlamydia Testing Among Men Who Have Sex With Men in China: a Cluster Randomized Controlled Trial
Verified date | January 2020 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 301 |
Est. completion date | September 2, 2019 |
Est. primary completion date | September 2, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 16 Years to 99 Years |
Eligibility |
Inclusion criteria: - born biologically male - age 16 years or older - report previous anal sex with another man - willing to provide mobile phone number for results notification Exclusion criteria: - tested for both gonorrhoea and chlamydia in the past 12 months with no high-risk sexual behavior following testing - previous participation in pay-it-forward program |
Country | Name | City | State |
---|---|---|---|
China | BlueD Danlan Happy Testing Office | Beijing | |
China | Southern Medical University | Guangzhou | Guangdong |
China | Zhitong Guangzhou LGBT Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | London School of Hygiene and Tropical Medicine, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Aging (NIA), SESH (Social Entrepreneurship to Spur Health), Southern Medical University, China, Yale University |
China,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
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. | 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 | 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. | 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. | 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 | 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. |
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. |
During enrollment visit, an approximate total of 1.5 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06468462 -
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
|
Phase 4 | |
Active, not recruiting |
NCT04553211 -
Expedited Partner Therapy and the HIV Prevention Cascade
|
N/A | |
Recruiting |
NCT05294588 -
Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae
|
Phase 2 |