NCT03330522

Brief Summary

Background: Love, Sex, and Choices (LSC) is a soap opera video series created to reduce HIV sex risk in women. Methods: LSC was compared to text messages in a randomized trial in 238 high-risk mostly Black young urban women. 117 received 12-weekly LSC videos, 121 received 12-weekly HIV prevention messages on smartphones. Changes in unprotected sex with high risk partners were compared by mixed models.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2011

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2014

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

October 23, 2017

Last Update Submit

October 31, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in unprotected sex risk with high risk partners from baseline to 6 months post-intervention

    Sex risk is measured by the Vaginal Episode Equivalent (VEE) score (Susser, Desvarieux, \& Wittkowski, 1998) with high risk partners. The VEE is the sum of all unprotected vaginal anal sex acts weighted by the relative HIV transmission risk (vaginal 1 and anal 2). A high risk partner is defined as the likelihood the male partner had sex with another woman, sex with men, or injected drugs in the past 3 months. Partner risk could range from 0 to 9; main or non-main partners with scores \> 0 were considered to engage in risk behavior. Multiple partners were considered high-risk. An HIV positive partner is high risk.There is a four-point response metric, from "Definitely not" (0) to "Definitely did" (3). Only women having unprotected sex with a partner they perceived to have risk \> 0 by this system were included into the study. For a given visit, unprotected vaginal and anal sex with all high risk partners in the previous 3 months were calculated at baseline and at 3 and 6 months.

    change in sex risk behavior from baseline to 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

The active intervention is "Love, Sex, \& Choices," a 12-episode, online HIV prevention intervention video series accessed on study provided smartphones. Each episode is up to 20 minutes in length. Study participants receive one episode per week for 12 weeks on study provided smartphones.

Other: Love, Sex, & Choices video series

Control Comparison Group

ACTIVE COMPARATOR

The control comparison intervention is twelve messages in text that promote HIV prevention behaviors and open communication with male sex partners. Study participants receive one message per week for 12 weeks on study provided smartphones.

Other: Messages in text

Interventions

Love, Sex, and Choices was written and scripted by the study team and underwent pilot testing in the target population. The series was divided into 15-to-20 minute episodes that were streamed weekly. The principles of reducing HIV risk were communicated through the characters and high risk situations. The lead characters model how women become more powerful, meaning more aware of themselves as worthy of respect, making choices intentionally, feeling free to pursue their intentions, and involving themselves in creating change. This process leads to higher power sex scripts in the characters, meaning pursuing intentional choices and health promoting behaviors. The lead characters model open communication about HIV testing with a resistant partner, and initiating condom use.

Intervention

The comparison group received 12 weekly HIV health promotion written messages over the smartphone. The messages were based on prevailing CDC recommendations and the theoretical framework. An example is: "Sexual health means respecting your own rights and feelings. Feeling pressured to have sex means limiting your choices and your freedom to love safely. …. If he doesn't like you being you, it may be time to walk." Other messages provided instructions on the correct condom use and the importance of HIV testing. The 12 messages were reviewed by ten African American and Latina undergraduate nursing students for ease of comprehension.

Control Comparison Group

Eligibility Criteria

Age18 Years - 29 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIdentify as female
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women 18-29 years old
  • Unprotected vaginal or anal sex with at least one man that they perceive as engaging in risky behavior OR
  • Unprotected vaginal or anal sex with more than 1 man regardless of perceived partner risk
  • Can understand written and spoken English

You may not qualify if:

  • Women younger than 18 years old
  • Women older than 29 years old
  • Cannot understand written or spoken English
  • Previously participated in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • Jones R, Hoover DR, Lacroix LJ. A randomized controlled trial of soap opera videos streamed to smartphones to reduce risk of sexually transmitted human immunodeficiency virus (HIV) in young urban African American women. Nurs Outlook. 2013 Jul-Aug;61(4):205-215.e3. doi: 10.1016/j.outlook.2013.03.006. Epub 2013 Jun 4.

  • Jones R, Lacroix LJ. Streaming weekly soap opera video episodes to smartphones in a randomized controlled trial to reduce HIV risk in young urban African American/black women. AIDS Behav. 2012 Jul;16(5):1341-58. doi: 10.1007/s10461-012-0170-9.

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSexual BehaviorRisk-Taking

Interventions

Sex

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Rachel Jones, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2017

First Posted

November 6, 2017

Study Start

November 26, 2008

Primary Completion

March 16, 2011

Study Completion

February 28, 2014

Last Updated

November 6, 2017

Record last verified: 2017-10

Locations