STI/HIV Prevention Intervention for Adolescents in Singapore
Primary Purpose
Sexually Transmitted Infections
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adolescent Behavioral Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Sexually Transmitted Infections focused on measuring Sexual behavior, condom use, secondary abstinence
Eligibility Criteria
Inclusion Criteria:
- Singaporean citizens or permanent residents
- Sexually active for the past 1 year
- Heterosexual
- Attending the clinic for the first time
- Able to commit for one year in Singapore
Exclusion Criteria:
- Involved in criminal investigation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard care
Adolescent Behavioral intervention
Arm Description
The control group will receive the standard care provided by the STI clinic.
Participants allocated to the intervention arm receive 4 on-site personalised counselling and 2 phone/online sessions over a 12-month period, targeting individual, relational, sociocultural and environmental factors pertaining to the acquisition of STI/HIV.
Outcomes
Primary Outcome Measures
Consistent condom use
This is assessed by: "Have you or your partner ever used a condom for vaginal sex in the last 6 months?" in the survey. Participants who gave the answer as 'Yes, always' are categorised as having consistent condom usage; whereas those who gave the answer as "Yes, sometimes", "No, not at all" and "Can't remember" are categorised as having inconsistent condom use.
Secondary abstinence
This is assessed by: "How many times did you have vaginal sex in the last 6 months?"
STI incidence
Defined as having a positive laboratory test result for a new episode of chlamydia, gonorrhoea, herpes, syphilis or HIV infection at either the 6-month or the 12-month assessment. Both gonorrhoea and chlamydia are detected by testing the urine specimens using Cobas Amplicor Polymerase Chain Reaction (PCR) assay. Type-specific serological tests (TSSTs) based on glycoprotein gG-1 and/or gG-2 are used to identify patients with genital herpes. Syphilis is screened using Enzyme Immunoassay (EIA) treponemal test. HIV rapid test is performed using the Determine HIV-1/HIV-2 (Abbott) rapid test kit, where results are available in 20 minutes. For those who do not want to wait may opt for the EIA test for HIV infection.
Number of sexual partners
This is is assessed by "How many persons did you have sex with in the last 6 months?"
Consistent condom use
This is assessed by: "Have you or your partner ever used a condom for vaginal sex in the last 6 months?" in the survey. Participants who gave the answer as 'Yes, always' are categorised as having consistent condom usage; whereas those who gave the answer as "Yes, sometimes", "No, not at all" and "Can't remember" are categorised as having inconsistent condom use.
Secondary abstinence
This is assessed by: "How many times did you have vaginal sex in the last 6 months?"
STI incidence
Defined as having a positive laboratory test result for a new episode of chlamydia, gonorrhoea, herpes, syphilis or HIV infection at either the 6-month or the 12-month assessment. Both gonorrhoea and chlamydia are detected by testing the urine specimens using Cobas Amplicor Polymerase Chain Reaction (PCR) assay. Type-specific serological tests (TSSTs) based on glycoprotein gG-1 and/or gG-2 are used to identify patients with genital herpes. Syphilis is screened using Enzyme Immunoassay (EIA) treponemal test. HIV rapid test is performed using the Determine HIV-1/HIV-2 (Abbott) rapid test kit, where results are available in 20 minutes. For those who do not want to wait may opt for the EIA test for HIV infection.
Number of sexual partners
This is assessed by "How many persons did you have sex with in the last 6 months?"
Secondary Outcome Measures
Success in stopping pressured sex
This is assessed by: "If a boy/ girl puts pressure on you to be involved sexually and you don't want to be involved, how often do you succeed in stopping it?"
Confidence in using condoms correctly
This is assessed by "How confident are you that you are using the condom correctly?" and rated on a scale ranging from "not confident at all" to "very confident"
Confidence in negotiating for condom use
This is evaluated by "How confident are you that you are able to persuade your boyfriend/girlfriend to use condom?"
Success in stopping pressured sex
This is assessed by: "If a boy/ girl puts pressure on you to be involved sexually and you don't want to be involved, how often do you succeed in stopping it?"
Confidence in using condoms correctly
This is assessed by "How confident are you that you are using the condom correctly?" and rated on a scale ranging from "not confident at all" to "very confident"
Confidence in negotiating for condom use
This is evaluated by "How confident are you that you are able to persuade your boyfriend/girlfriend to use condom?"
Full Information
NCT ID
NCT02461940
First Posted
May 28, 2015
Last Updated
May 6, 2016
Sponsor
National University of Singapore
Collaborators
National Medical Research Council (NMRC), Singapore, National Skin Centre, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02461940
Brief Title
STI/HIV Prevention Intervention for Adolescents in Singapore
Official Title
A Randomized Controlled Trial of an STI/HIV/AIDS Prevention Intervention for Adolescents Attending a Public STI Clinic in Singapore
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
National Medical Research Council (NMRC), Singapore, National Skin Centre, Singapore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized controlled trial conducted on 688 sexually experienced adolescents, with 337 participants assigned to the routine program, and 351 to the new intervention developed from an assessment of their needs. All participants will complete a self-administered questionnaire and an interview on their knowledge of sexually transmitted infections (STIs)/Human Immunodeficiency Virus (HIV), self-efficacy, skills in negotiating for sexual abstinence or condom use, and sexual behaviors at baseline and at 6- and 12-months' post- intervention. All will be tested for STIs. Participants in the intervention group will receive 4 individual counseling sessions on STIs/HIV knowledge, life skills, secondary abstinence, safer sex and healthy relationships over 1 year. They will also be referred to counselors for proactive social and emotional support delivered through electronic media and other means. The control group will receive the usual counseling session at first and follow-up clinic visit.
Detailed Description
The reasons for conducting this study in a clinical setting is threefold.
This is group of adolescents that has a high risk for transmitting STIs to the community. Prior to this intervention, the investigators did a preliminary study and found a high number of sex partners (median: 4, range: 1-25) and high prevalence of unprotected sex (90%) and STIs (60%) in this group. Other factors in this group that facilitate the transmission of STIs is that 36% continued to engage in unprotected sex and half of the boys (49%) and three quarters of the girls (77%) delayed seeking treatment for more than a week after experiencing symptoms of STIs. The rate at which STIs spread in a population depends upon the average number of new cases of infection generated by an infected person (the basic or case reproduction ratio (Ro). This ratio, in turn, depends upon the efficiency of transmission, (b), the mean rate of change of sexual partners (c), and the average duration of infectiousness (D) as expressed in the form: Ro=b*c*D. Given their high number of sex partners and the long duration of infectiousness owing to their delay in seeking treatment, they would form an important group for spreading STIs to the general population.
The investigators are able to adopt a rigorous study design, that is, a randomized controlled trial in a clinical setting to evaluate the efficacy of the intervention, and validate self-reported behaviors with laboratory tests for STIs. In contrast, it is less feasible to conduct the study in schools presently because of the sensitivity of the topic, conservative attitudes of parents and possible biases of self-reported sexual behavior in schools. School-based interventions will also exclude school drop outs, who were found in this ongoing study, to be significantly, more likely to engage in sexual activity.
The investigators have conducted needs assessment of this group and this would help in developing interventions specifically for them. For instance, the investigators found that both males and females lack the confidence of using condoms correctly. The investigators incorporated a session on instilling skills for condom use in our intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infections
Keywords
Sexual behavior, condom use, secondary abstinence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
688 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
The control group will receive the standard care provided by the STI clinic.
Arm Title
Adolescent Behavioral intervention
Arm Type
Active Comparator
Arm Description
Participants allocated to the intervention arm receive 4 on-site personalised counselling and 2 phone/online sessions over a 12-month period, targeting individual, relational, sociocultural and environmental factors pertaining to the acquisition of STI/HIV.
Intervention Type
Behavioral
Intervention Name(s)
Adolescent Behavioral Intervention
Intervention Description
Session 1 focuses on STI/HIV education and self-reflection. Session 2 aims to increase the awareness of STI/HIV preventive strategies by instilling condom use and negotiation skills. Motivational Interviewing is used during the behavioural counselling. Session 3 reviews the goal on safer sex set by the participant and examines the successful strategies on safer sex and identifies triggers for relapse. Success stories are shared to renew their motivation. Session 4 reinforces the progress of the participant by recapitulating the knowledge and motivation explored in previous sessions. The online sessions, by phone/SMS/Whatsapp are conducted 2 months after the second and third sessions to find out if they face any difficulties and to reinforce prevention information covered previously.
Primary Outcome Measure Information:
Title
Consistent condom use
Description
This is assessed by: "Have you or your partner ever used a condom for vaginal sex in the last 6 months?" in the survey. Participants who gave the answer as 'Yes, always' are categorised as having consistent condom usage; whereas those who gave the answer as "Yes, sometimes", "No, not at all" and "Can't remember" are categorised as having inconsistent condom use.
Time Frame
12 months
Title
Secondary abstinence
Description
This is assessed by: "How many times did you have vaginal sex in the last 6 months?"
Time Frame
12 months
Title
STI incidence
Description
Defined as having a positive laboratory test result for a new episode of chlamydia, gonorrhoea, herpes, syphilis or HIV infection at either the 6-month or the 12-month assessment. Both gonorrhoea and chlamydia are detected by testing the urine specimens using Cobas Amplicor Polymerase Chain Reaction (PCR) assay. Type-specific serological tests (TSSTs) based on glycoprotein gG-1 and/or gG-2 are used to identify patients with genital herpes. Syphilis is screened using Enzyme Immunoassay (EIA) treponemal test. HIV rapid test is performed using the Determine HIV-1/HIV-2 (Abbott) rapid test kit, where results are available in 20 minutes. For those who do not want to wait may opt for the EIA test for HIV infection.
Time Frame
12 months
Title
Number of sexual partners
Description
This is is assessed by "How many persons did you have sex with in the last 6 months?"
Time Frame
12 months
Title
Consistent condom use
Description
This is assessed by: "Have you or your partner ever used a condom for vaginal sex in the last 6 months?" in the survey. Participants who gave the answer as 'Yes, always' are categorised as having consistent condom usage; whereas those who gave the answer as "Yes, sometimes", "No, not at all" and "Can't remember" are categorised as having inconsistent condom use.
Time Frame
6 months
Title
Secondary abstinence
Description
This is assessed by: "How many times did you have vaginal sex in the last 6 months?"
Time Frame
6 months
Title
STI incidence
Description
Defined as having a positive laboratory test result for a new episode of chlamydia, gonorrhoea, herpes, syphilis or HIV infection at either the 6-month or the 12-month assessment. Both gonorrhoea and chlamydia are detected by testing the urine specimens using Cobas Amplicor Polymerase Chain Reaction (PCR) assay. Type-specific serological tests (TSSTs) based on glycoprotein gG-1 and/or gG-2 are used to identify patients with genital herpes. Syphilis is screened using Enzyme Immunoassay (EIA) treponemal test. HIV rapid test is performed using the Determine HIV-1/HIV-2 (Abbott) rapid test kit, where results are available in 20 minutes. For those who do not want to wait may opt for the EIA test for HIV infection.
Time Frame
6 months
Title
Number of sexual partners
Description
This is assessed by "How many persons did you have sex with in the last 6 months?"
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Success in stopping pressured sex
Description
This is assessed by: "If a boy/ girl puts pressure on you to be involved sexually and you don't want to be involved, how often do you succeed in stopping it?"
Time Frame
12 months
Title
Confidence in using condoms correctly
Description
This is assessed by "How confident are you that you are using the condom correctly?" and rated on a scale ranging from "not confident at all" to "very confident"
Time Frame
12 months
Title
Confidence in negotiating for condom use
Description
This is evaluated by "How confident are you that you are able to persuade your boyfriend/girlfriend to use condom?"
Time Frame
12 months
Title
Success in stopping pressured sex
Description
This is assessed by: "If a boy/ girl puts pressure on you to be involved sexually and you don't want to be involved, how often do you succeed in stopping it?"
Time Frame
6 months
Title
Confidence in using condoms correctly
Description
This is assessed by "How confident are you that you are using the condom correctly?" and rated on a scale ranging from "not confident at all" to "very confident"
Time Frame
6 months
Title
Confidence in negotiating for condom use
Description
This is evaluated by "How confident are you that you are able to persuade your boyfriend/girlfriend to use condom?"
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Singaporean citizens or permanent residents
Sexually active for the past 1 year
Heterosexual
Attending the clinic for the first time
Able to commit for one year in Singapore
Exclusion Criteria:
Involved in criminal investigation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mee-Lian Wong, MPH, MD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19564268
Citation
Wong ML, Chan RK, Koh D, Tan HH, Lim FS, Emmanuel S, Bishop G. Premarital sexual intercourse among adolescents in an Asian country: multilevel ecological factors. Pediatrics. 2009 Jul;124(1):e44-52. doi: 10.1542/peds.2008-2954.
Results Reference
background
PubMed Identifier
23000347
Citation
Wong ML, Chan RK, Tan HH, Sen P, Chio M, Koh D. Gender differences in partner influences and barriers to condom use among heterosexual adolescents attending a public sexually transmitted infection clinic in Singapore. J Pediatr. 2013 Mar;162(3):574-80. doi: 10.1016/j.jpeds.2012.08.010. Epub 2012 Sep 20.
Results Reference
background
PubMed Identifier
8312288
Citation
Kipke MD, Boyer C, Hein K. An evaluation of an AIDS risk reduction education and skills training (ARREST) program. J Adolesc Health. 1993 Nov;14(7):533-9. doi: 10.1016/1054-139x(93)90136-d.
Results Reference
background
PubMed Identifier
16710492
Citation
Sen P, Chio MT, Tan HH, Chan RK. Rising trends of STIs and HIV infection in Singapore-- a review of epidemiology over the last 10 years (1994 to 2003). Ann Acad Med Singap. 2006 Apr;35(4):229-35.
Results Reference
background
PubMed Identifier
23303119
Citation
Wong ML, Sen P, Wong CM, Tjahjadi S, Govender M, Koh TT, Yusof Z, Chew L, Tan A, K V. Human immunodeficiency virus (HIV) prevention education in Singapore: challenges for the future. Ann Acad Med Singap. 2012 Dec;41(12):602-9.
Results Reference
background
PubMed Identifier
29661642
Citation
Ng JYS, Chan RKW, Chio MT, Lim RBT, Koh D, Wong ML. An Abstinence and Safer Sex Intervention for Adolescents Attending the Public Sexually Transmitted Infection Clinic in Singapore. J Adolesc Health. 2018 Jun;62(6):737-746. doi: 10.1016/j.jadohealth.2017.12.014. Epub 2018 Apr 13.
Results Reference
derived
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STI/HIV Prevention Intervention for Adolescents in Singapore
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