Pay-it-forward RCT for Gonorrhea and Chlamydia Testing

Pay-it-forward Gonorrhea and Chlamydia Testing Among Men Who Have Sex With Men in China: a Cluster Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03741725

Enrollment

301

Registered

2018-11-15

Start date

2018-12-08

Completion date

2019-09-02

Last updated

2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia;M, Gonorrhea Male

Brief summary

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.

Detailed description

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.

Interventions

OTHERPay-it-forward

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.

OTHERPay-what-you-want

Participants will be offered gonorrhoea and chlamydia testing and told that they can decide and pay any desired amount after receiving the test.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Intervention model description

3-arm superiority randomized controlled

Eligibility

Sex/Gender

MALE

Age

16 Years to 99 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Received the Dual Gonorrhea/Chlamydia Testing	During enrollment visit, an approximate total of 1.5 hours	Dual gonorrhea/chlamydia test uptake as assessed by administrative records in each arm.

Secondary

Measure	Time frame	Description
Number of Participants Tested Positive for Chlamydia	During enrollment visit, an approximate total of 1.5 hours	The is the number of men who tested positive for chlamydia through this study
Cost Per Test	During enrollment visit, an approximate total of 1.5 hours	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.
Cost Per Diagnosis	During enrollment visit, an approximate total of 1.5 hours	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.
Number of Participants Tested Positive for Gonorrhea	During enrollment visit, an approximate total of 1.5 hours	The number of men who tested positive for gonorrhea through this study. Samples were collected either from urine or rectum.
Community Connectedness Scale Scores	During enrollment visit, an approximate total of 1.5 hours	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.
Social Cohesion Scale Scores	During enrollment visit, an approximate total of 1.5 hours	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.
Number of Participants Reporting Community Engagement Activities	During enrollment visit, an approximate total of 1.5 hours	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

Countries

China

Participant flow

Participants by arm

Arm	Count
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.	101
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.	100
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.	100
Total	301

Baseline characteristics

Characteristic	Pay-it-forward	Total	Standard-of-care	Pay-what-you-want
Age, Continuous	28.6 years STANDARD_DEVIATION 7.8	28.1 years STANDARD_DEVIATION 7.1	29.1 years STANDARD_DEVIATION 7.5	26.6 years STANDARD_DEVIATION 5.6
Age, Customized <= 30 years	66 Participants	206 Participants	66 Participants	74 Participants
Age, Customized >30 years	32 Participants	82 Participants	31 Participants	19 Participants
Annual income (USD) >14,294	40 Participants	110 Participants	37 Participants	33 Participants
Annual income (USD) <2,680	11 Participants	33 Participants	9 Participants	13 Participants
Annual income (USD) 2,681- 5,360	7 Participants	26 Participants	10 Participants	9 Participants
Annual income (USD) 5,361- 8,934	17 Participants	43 Participants	11 Participants	15 Participants
Annual income (USD) 8,935- 14,294	23 Participants	76 Participants	30 Participants	23 Participants
Condom use frequency during anal sex in the past three months Always	52 Participants	127 Participants	40 Participants	35 Participants
Condom use frequency during anal sex in the past three months Non-use	5 Participants	14 Participants	4 Participants	5 Participants
Condom use frequency during anal sex in the past three months Often	21 Participants	69 Participants	24 Participants	24 Participants
Condom use frequency during anal sex in the past three months Sometimes	6 Participants	24 Participants	9 Participants	9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	101 Participants	301 Participants	100 Participants	100 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Had anal sex in the past three months No	14 Participants	53 Participants	19 Participants	20 Participants
Had anal sex in the past three months Yes	84 Participants	234 Participants	77 Participants	73 Participants
Highest education completed College or above	85 Participants	245 Participants	81 Participants	79 Participants
Highest education completed High/vocational school	8 Participants	27 Participants	10 Participants	9 Participants
Highest education completed Middle school or below	5 Participants	16 Participants	6 Participants	5 Participants
HIV testing frequency in the past two years Every six months	26 Participants	76 Participants	26 Participants	24 Participants
HIV testing frequency in the past two years Every three months	21 Participants	73 Participants	27 Participants	25 Participants
HIV testing frequency in the past two years Monthly	7 Participants	16 Participants	4 Participants	5 Participants
HIV testing frequency in the past two years Never tested	6 Participants	26 Participants	6 Participants	14 Participants
HIV testing frequency in the past two years Once a year	23 Participants	63 Participants	24 Participants	16 Participants
HIV testing frequency in the past two years < once every two years	15 Participants	33 Participants	9 Participants	9 Participants
Marital status Never married	87 Participants	252 Participants	81 Participants	84 Participants
Marital status Other (engaged, married, divorced or separated)	11 Participants	36 Participants	16 Participants	9 Participants
Number of sex partners in the past three months, Categorical 0-1	47 Participants	136 Participants	42 Participants	47 Participants
Number of sex partners in the past three months, Categorical Multiple	49 Participants	142 Participants	49 Participants	44 Participants
Region of Enrollment China	101 participants	301 participants	100 participants	100 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	101 Participants	301 Participants	100 Participants	100 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 101	0 / 100	0 / 100
other Total, other adverse events	0 / 101	0 / 100	0 / 100
serious Total, serious adverse events	0 / 101	0 / 100	0 / 100