Prevention of HIV/AIDS and STDs in Women Over Fifty

NCT03810170 | Completed Phase 2

• 1 other identifier: R44AG034707
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 1

Brief Summary

In response to the increasing rates of HIV/STD infections among women over the age of 50, especially minority women, and in the attempt to reduce HIV/STD risks for over ten million older adult American women who are impacted by gray divorce and at risk for unsafe sex, the investigators will create, test, and commercialize a novel positive psychology-based "SmartWeb" intervention to promote wellbeing, HIV/STD awareness, and safe sex practices among culturally-diverse older divorced or separated women who are dating. This large end-user market for the proposed HIV/STD risk reduction intervention will greatly facilitate commercialization through advertisements, marketing research based on data mining, and in collaboration with manufacturers of condoms, and other large companies offering health products and services to older women.

Conditions

Hiv; Sexually Transmitted Diseases; Aging

Outcome Measures

Primary Outcomes (1)

• intention to engage in safe sex questionnaire

  A three-item intention to engage in safe sex practices instrument. Participants will answer 3 questions, validated for this population (Fisher et al., 1998; Mausbach et al., 2009), regarding their intentions to use protection during sex over the next two months (e.g., "I intend to always use condoms during vaginal sex with all of my partners during the next two months") Responses are on a 5-point Likert scale, 1 = "Very Untrue" and 5 = "Very True". The score ranges from 3 to 15. The higher score indicate better intention to engage in safe sex.

  90 days

Secondary Outcomes (4)

• safe sex self-efficacy questionnaire

  90 days

• HIV transmission knowledge questionnaire

  90 days

• perceived sexual/HIV risk questionnaire

  90 days

• positive affect questionnaire

  90 days

Study Arms (2)

control

ACTIVE COMPARATOR

control group receives 2 page written materials on safe sex and HIV/STD prevention education, as well as weekly emails on general women's health topics

Other: written materials on safe sex

intervention

EXPERIMENTAL

intervention group receives safe sex and HIV/STD prevention education via a website, and weekly emails on with positive psychology-based happiness and resilience boosting activities

Behavioral: safe sex and HIV/STD prevention education via a website

Interventions

safe sex and HIV/STD prevention education via a website BEHAVIORAL

website providing positive psychology-based advice and education for women over the age of 50 who are divorced. embedded in site is safe sex education.

intervention

written materials on safe sex OTHER

2 page written materials on safe sex and HIV/STD prevention education, as well as weekly emails on general women's health topics

control

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• divorced or separated women
• years of age and older
• who are dating or thinking of dating in the near future
• HIV negative
• access to internet via computer or smartphone
• English primary language

You may not qualify if:

• currently married
• HIV positive
• participating in another research study or clinical trial
• do not own home computer with internet access or smartphone

Sponsors & Collaborators

• Environment and Health Group, Inc.: lead

Study Sites (1)

Environment and Health Group

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: January 18, 2019
• Study Start: September 1, 2009
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)