STI/HIV Prevention Intervention for Adolescents in Singapore

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of an STI/HIV/AIDS Prevention Intervention for Adolescents Attending a Public STI Clinic in Singapore

Conditions
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Sexually Transmitted Infections

Intervention / Treatment
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* Behavioral: Adolescent Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>The control group will receive the standard care provided by the STI clinic. | |
| Active Comparator: Adolescent Behavioral intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| Secondary abstinence | This is assessed by: How many times did you have vaginal sex in the last 6 months? | 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. | 12 months | 
| Number of sexual partners | This is is assessed by How many persons did you have sex with in the last 6 months? | 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. | 6 months | 
| Secondary abstinence | This is assessed by: How many times did you have vaginal sex in the last 6 months? | 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. | 6 months | 
| Number of sexual partners | This is assessed by How many persons did you have sex with in the last 6 months? | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 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 | 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? | 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? | 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 | 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? | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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condom use, Sexual behavior, secondary abstinence