Clinical trial NCT01387646: Behavioral Intervention for Minority Adolescent Women
Official title: Behavioral Intervention for Minority Adolescent Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sexually Transmitted Infection
Substance Use
Abuse
Pregnancy
Keywords: STI, abuse, substance use, unintended pregnancy
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-07-04
Enrollment: 562
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this Stage II clinical trial is to test the efficacy of a culturally sensitive, cognitive-behavioral intervention to reduce sexual risk behavior among minority adolescents for prevention of sexually transmitted infection (STI/HIV), unintended pregnancy and abuse by changing high-risk sexual behaviors, decreasing substance use and encouraging contraceptive use. Its primary goal is to expand risk-reduction interventions created in previous studies to further increase intervention efficacy for this particularly vulnerable, high-risk group. An adolescent intervention has been created and pilot tested in developmental studies. Results indicated reductions in substance use, risk behaviors, unintended pregnancy, STI and abuse without reports of adverse outcomes. Specific aims of the current study include: 1) To obtain a more in-depth understanding of configurations of psychosocial and situational factors associated with high-risk sexual behavior, substance use, STI/HIV and contraceptive use among abused minority adolescent women with STI; 2) To implement a controlled randomized trial of a cognitive behavioral risk-reduction intervention consisting of 2 small group sessions, 2 individual counseling and 3 support groups for this group; 3) To evaluate the effects of the adolescent intervention model versus enhanced counseling for this group on AIDS Risk Reduction Model (ARRM)-related constructs, high-risk sexual behavior, substance use, abuse recurrence, contraceptive use, unintended pregnancy and STI/HIV at 6 and 12 months follow-up. Participants will include a convenience sample of 600 Mexican-and African American adolescent women, aged 14-18 years with a history of sexual or physical abuse and current STI.

Detailed description: African-and Mexican-American adolescent women with a current STI and history of abuse will be identified at public health and STI clinics within the San Antonio Metropolitan Health District system. Women who agree to participate and give informed consent will be randomized into the intervention or control arm. Women in the control arm will be interviewed at baseline, be given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and will receive abuse and enhanced clinical counseling. Women in the intervention arm will be interviewed at baseline, given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and enrolled in the intervention. Women in the intervention arm will be interviewed and examined again after completing the intervention, to establish a post-intervention baseline. All women in the study will be followed over one year, with follow-up interviews including an inquiry about any Adverse Events (AEs) or Serious Adverse Events (SAEs), and a targeted physical exams and contraception counseling at 6 and 12 months. During the study period, women will be encouraged to return to the study clinic for problem visits if they suspect they have been infected with a STI or require contraception or abuse counseling. All analyses of intervention effects will be performed on an intent-to-treat basis.

Eligibility criteria: Inclusion Criteria:

* Aged 14-18 years, Mexican-or African-American female with a history of STI or abuse seeking health care through the San Antonio Metropolitan Health District.

Exclusion Criteria:

* No history of STI or abuse

Primary outcomes:
measure: Sexually transmitted infection
timeFrame: 12 months
Secondary outcomes:
measure: Substance Use
timeFrame: 12 months
measure: Experience of abuse
timeFrame: 12 months
measure: Unintended pregnancy
timeFrame: 12 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio Metropolitan Health District
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Jane D Champion, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collins JL, Owen DC, Champion JD. The Meaning of Weight: A Big Way of Life for Rural Mexican-American Adolescent Men and Caregivers. Public Health Nurs. 2016 Sep;33(5):421-9. doi: 10.1111/phn.12263. Epub 2016 Apr 14.
citation: Collins JL, Champion JD. Assessment of mobile device and SMS Use for Diet and Exercise Information Among Rural Mexican-American adolescents. J Pediatr Nurs. 2014 Nov-Dec;29(6):493-502. doi: 10.1016/j.pedn.2014.03.020. Epub 2014 Mar 15.
citation: Dimmitt Champion J, Harlin B, Collins JL. Sexual risk behavior and STI health literacy among ethnic minority adolescent women. Appl Nurs Res. 2013 Nov;26(4):204-9. doi: 10.1016/j.apnr.2013.06.003. Epub 2013 Jul 15.