NCT Number: NCT02544841
The purpose of the study is to determine the impact of the offer to participate in Safer Sex Intervention (SSI) (treatment) relative to the offer to participate in Female Sexual Health (control) on three self-reported sexual behaviors (condom use, other contraceptive use, and frequency of sex) six months after the end of treatment.
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Notify Me14 year–19 year
Female
Interventional
Not applicable
The Policy & Research Group (PRG) will be evaluating the Safer Sex Intervention (SSI). The Safer Sex Intervention is based in Social Cognitive Theory, the Transtheoretical Model of Behavior Change, and motivational interviewing. Coupled with skill-building exercises, the intervention is intended to increase knowledge related to risk and safe-sex behaviors, to increase awareness of risk and need for behavior change, to help build self-efficacy to engage in safe-sex behaviors, and, ultimately, to motivate participants to engage in and maintain safe sex practices. The intervention is meant to be delivered in four, one-on-one sessions over the course of six months. Each session is to be conducted in a private setting by a female health educator trained in motivational interviewing and Safer Sex Intervention. The initial or primary intervention session should take approximately 30 to 50 minutes. Subsequent "booster sessions" delivered 1, 3, and 6 months following the initial session are to take 10 to 30 minutes. Booster sessions are intended to sustain any resulting behavior change. The control (counterfactual) condition, Female Sexual Health, was developed specifically for use in this study; it consists of a 30-minute PowerPoint presentation, intended to be delivered in one face-to-face session that provides information about reproductive anatomy and STIs. After the presentation, participants receive free condoms. This is the only session for the control condition; there are no booster sessions. Though there were some variations in consent requirements across sites, there were no differences in the recruitment process between the treatment and control groups. All eligible individuals who provided the proper consent to participate were randomized and enrolled into the study at the time they attended their first scheduled study session. Data were collected via self-administered questionnaires that were scheduled at baseline and six months post treatment (12 months after baseline). The study took place in New Orleans, Louisiana, at five clinics that served young women between the ages of 14 and 19.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Between the ages of 14-19 Had engaged in sex with a male in the three months prior to enrollment Provide parental consent (if under age 18) and participant assent to participate in the study.
Exclusion criteria
Not have previously participated in any of the following pregnancy/HIV prevention programs:
Safer Sex Intervention (SSI) is an in-person, individual-level, clinic-based intervention implemented by a female health educator trained in the intervention. It is intended to be implemented in one initial session lasting 30-50 minutes and three booster sessions lasting 10-30 minutes at one, three, and six month intervals.
Female Sexual Health is a knowledge-based intervention that intends to provide information on how STIs are contracted, the consequences of contracting STIs, and how to prevent them. Female Sexual Health includes the information-only component of the first session of SSI and baseline exposure to a health educator but does not include booster sessions.
Time frame: 6 months after the end of intervention
The risk outcome is operationalized as the proportion of times in the past three months a person reports having any type of sex without using a condom. The measure is calculated from the following items on the Outcome Questionnaire administered 6 months after the program ends:
Time frame: 6 months after end of intervention
The risk outcome is operationalized as the proportion of times a person reports having sexual intercourse without using any form of birth control (including condoms). The measure is calculated from the following items:
The measure is calculated by dividing the total number of times a person reported having sexual intercourse without using any contraception by the total number of times she reported having sexual intercourse.
Time frame: 6 months after end of intervention
The risk outcome is operationalized as the number of times in the past three months a person reports having any type of sex.
The measure is taken directly from the following item:
The variable is continuous, with values ranging from 0 to k, where 0= no sexual activity reported in past 3 months and k = number of times sex reported.
The Policy & Research Group
Other
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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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