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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
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Infections focused on measuring Sexual behavior, condom use, secondary abstinence

Eligibility Criteria

16 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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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