Clinical trial NCT02461940: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infections
Keywords: Sexual behavior
condom use
secondary abstinence
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
name: National Skin Centre, Singapore
First posted: 2015-06-03
Enrollment: 688
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Consistent condom use
timeFrame: 12 months
measure: Secondary abstinence
timeFrame: 12 months
measure: STI incidence
timeFrame: 12 months
measure: Number of sexual partners
timeFrame: 12 months
measure: Consistent condom use
timeFrame: 6 months
measure: Secondary abstinence
timeFrame: 6 months
measure: STI incidence
timeFrame: 6 months
measure: Number of sexual partners
timeFrame: 6 months
Secondary outcomes:
measure: Success in stopping pressured sex
timeFrame: 12 months
measure: Confidence in using condoms correctly
timeFrame: 12 months
measure: Confidence in negotiating for condom use
timeFrame: 12 months
measure: Success in stopping pressured sex
timeFrame: 6 months
measure: Confidence in using condoms correctly
timeFrame: 6 months
measure: Confidence in negotiating for condom use
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: National University of Singapore
name: Mee-Lian Wong, MPH, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.