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STI/HIV Prevention Intervention for Adolescents in Singapore

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ClinicalTrials.gov Identifier: NCT02461940
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : May 10, 2016
Sponsor:
Collaborators:
National Medical Research Council (NMRC), Singapore
National Skin Centre, Singapore
Information provided by (Responsible Party):
Wong Mee Lian, National University, Singapore

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.

Condition or disease Intervention/treatment Phase
Sexually Transmitted Infections Behavioral: Adolescent Behavioral Intervention Not Applicable

Detailed Description:

The reasons for conducting this study in a clinical setting is threefold.

  1. 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.
  2. 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.
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 688 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of an STI/HIV/AIDS Prevention Intervention for Adolescents Attending a Public STI Clinic in Singapore
Study Start Date : November 2009
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard care
The control group will receive the standard care provided by the STI clinic.
Active Comparator: Adolescent Behavioral intervention
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.




Primary Outcome Measures :
  1. Consistent condom use [ Time Frame: 12 months ]
    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.

  2. Secondary abstinence [ Time Frame: 12 months ]
    This is assessed by: "How many times did you have vaginal sex in the last 6 months?"

  3. STI incidence [ Time Frame: 12 months ]
    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.

  4. Number of sexual partners [ Time Frame: 12 months ]
    This is is assessed by "How many persons did you have sex with in the last 6 months?"

  5. Consistent condom use [ Time Frame: 6 months ]
    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. Secondary abstinence [ Time Frame: 6 months ]
    This is assessed by: "How many times did you have vaginal sex in the last 6 months?"

  7. STI incidence [ Time Frame: 6 months ]
    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.

  8. Number of sexual partners [ Time Frame: 6 months ]
    This is assessed by "How many persons did you have sex with in the last 6 months?"


Secondary Outcome Measures :
  1. Success in stopping pressured sex [ Time Frame: 12 months ]
    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?"

  2. Confidence in using condoms correctly [ Time Frame: 12 months ]
    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"

  3. Confidence in negotiating for condom use [ Time Frame: 12 months ]
    This is evaluated by "How confident are you that you are able to persuade your boyfriend/girlfriend to use condom?"

  4. Success in stopping pressured sex [ Time Frame: 6 months ]
    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?"

  5. Confidence in using condoms correctly [ Time Frame: 6 months ]
    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. Confidence in negotiating for condom use [ Time Frame: 6 months ]
    This is evaluated by "How confident are you that you are able to persuade your boyfriend/girlfriend to use condom?"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461940


Sponsors and Collaborators
National University, Singapore
National Medical Research Council (NMRC), Singapore
National Skin Centre, Singapore
Investigators
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Principal Investigator: Mee-Lian Wong, MPH, MD National University, Singapore

Publications:
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Responsible Party: Wong Mee Lian, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT02461940     History of Changes
Other Study ID Numbers: NMRC/1188/2008
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016

Keywords provided by Wong Mee Lian, National University, Singapore:
Sexual behavior
condom use
secondary abstinence

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female