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Completed

NCT Number: NCT02461940

STI/HIV Prevention Intervention for Adolescents in Singapore

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.

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Key information

Conditions

Sexually Transmitted Infections Behavior Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Behavior Sexually Transmitted Diseases Urogenital Diseases

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adolescent Behavioral Intervention

Behavioral

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 outcomes

  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 outcomes

  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?"

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore
  • National Skin Centre, Singapore

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2015
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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