NCT02493647

Brief Summary

This study tests a 12-episode Internet-based, guide enhanced Love, Sex, \& Choices (LSC) HIV prevention soap opera video series for smartphones or computers, in a randomized clinical trial among predominately at-risk African American urban women. The following hypotheses are to be tested: 1) The LSC treatment arm will show lower unprotected sex risk, meaning lower frequency of unprotected sex (vaginal + anal) with high risk partners at 6 months post intervention compared to an attention control arm 2) The LSC treatment arm will show higher participation in HIV testing at 6 months post intervention compared to the control. If effective, this video intervention could be rapidly implemented and brought to scale at low cost via the Internet, widely reaching young urban women with the goal of reducing HIV risk behavior and increasing HIV testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
814

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable hiv

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

June 24, 2015

Last Update Submit

August 21, 2019

Conditions

HIVSexual BehaviorWomen's RoleRisk BehaviorChlamydia

Outcome Measures

Primary Outcomes (2)

  • Frequency of unprotected vaginal or anal sex with perceived high risk male partner

    test hypothesis that the LSC treatment arm will show lower unprotected sex risk, meaning lower frequency of unprotected sex (vaginal + anal) with high risk partners at 6 months post intervention compared to an attention control arm

    6 months

  • Incidence of HIV testing

    Test hypothesis that the LSC treatment arm will show higher participation in HIV testing at 6 months post intervention compared to the control

    6 months

Secondary Outcomes (3)

  • composite demographic measure

    6 months

  • Attrition

    6 months

  • Identification with Character Scale

    1 month

Study Arms (2)

Love, Sex, & Choices

EXPERIMENTAL

Love, Sex, and Choices (LSC) is an engaging 12-episode video series to reduce HIV risk in young, adult predominately Black women. A peer video guide was added to the end of LSC episodes to provoke viewers to question their own sex scripts and consider their own need for change. Investigators propose to conduct a two-arm clinical trial of guide enhanced LSC impact on reducing unprotected sex with high risk partners and increasing HIV testing in Black women in high HIV prevalence neighborhoods.

Behavioral: Love, Sex, & Choices

Attention-Time Control

NO INTERVENTION

The Control is a 12-episode popular web miniseries with a storyline that promotes respectful relationships. time and frequency are matched to the active intervention.

Interventions

Love, Sex, & ChoicesBEHAVIORAL

Investigators propose to conduct a two-arm clinical trial of guide enhanced LSC impact on reducing unprotected sex with high risk partners and increasing HIV testing in Black women in high HIV prevalence neighborhoods. Undiagnosed HIV is a significant factor fueling the epidemic. Recruitment into the study will be via Facebook or traditional on the ground.

Also known as: guide enhanced Love, Sex, & Choices
Love, Sex, & Choices

Eligibility Criteria

Age18 Years - 29 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • sexual relationship with a man in previous 3 months
  • speak and read English

You may not qualify if:

  • younger than 18 years old
  • older than 29 years old
  • currently pregnant
  • women who have already participated in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sexual BehaviorRisk-TakingChlamydia Infections

Interventions

Sex

Condition Hierarchy (Ancestors)

BehaviorChlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 9, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 22, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)