An interventional study of Adolescent Behavioral Intervention in Sexually Transmitted Infections, sponsored by National University of Singapore. Completed. Open to participants aged 16 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-10.
Sponsored by National University of Singapore · Not applicable, Interventional, and Prevention
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.
The reasons for conducting this study in a clinical setting is threefold.
424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.
This study's enrollment of 688 is above the median of 470 across 346 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →National University of Singapore is the lead sponsor of 206 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Adolescent Behavioral Intervention
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.
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.
Time frame: 12 months
Secondary abstinence
This is assessed by: "How many times did you have vaginal sex in the last 6 months?"
Time frame: 12 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.
Time frame: 12 months
Number of sexual partners
This is is assessed by "How many persons did you have sex with in the last 6 months?"
Time frame: 12 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.
Time frame: 6 months
Secondary abstinence
This is assessed by: "How many times did you have vaginal sex in the last 6 months?"
Time frame: 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.
Time frame: 6 months
Number of sexual partners
This is assessed by "How many persons did you have sex with in the last 6 months?"
Time frame: 6 months
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?"
Time frame: 12 months
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"
Time frame: 12 months
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?"
Time frame: 12 months
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?"
Time frame: 6 months
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"
Time frame: 6 months
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?"
Time frame: 6 months
No study locations are listed for this record.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Sexually Transmitted Diseases→
National University of Singapore