Prevention of HIV/AIDS and STDs in Women Over Fifty

NCT ID: NCT03810170

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 331 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-01
• Study Completion Date: 2018-06-30

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.

Detailed Description

Older adult women (age 50+) account for almost a third of the U.S. HIV/AIDS population, and infection rates among this group are increasing. The overall goal of the proposed Phase II application is to develop a culturally-sensitive, gender-specific, and age-appropriate HIV prevention intervention for older women, especially African American and Latino women who are at disproportionally high risk for HIV/STD infection. The target population is the growing number of divorced/separated older women for whom interventions have not been developed and, due to cohort and social contextual factors, are likely unaware that they are at risk, and more likely than single (never married) women to forgo condom use. Building on Phase I and ARRA study results, the Phase II objectives are to create, test, and commercialize a positive psychology-based "SmartWeb" intervention to promote wellbeing and safe sex practices among culturally diverse older divorced or separated women who are dating or planning on dating. Specific Phase II Aims are: 1) Create the SmartWeb intervention; 2) Evaluate its effectiveness in a randomized controlled trial (RCT) of divorced/separated women over 50; and 3) Prepare marketing and commercialization plans for the SmartWeb intervention.

Consistent with Phase I objectives, i.e., developing content to address Stages 1-3 of the M-AARM theoretical model, the proposed Phase II includes new components to address M-AARM Stages 4-5. The Phase II is also responsive to Phase I evaluation findings, including the desire for mobile access, membership; video interviews with experts in women's health, positive aging, HIV/STD prevention in culturally diverse communities, safe sex negotiation strategies, and gray divorce; online community, and positive psychology- based self-efficacy and affect-boosting emails, as well as expanded versions of Phase I components to reinforce stages 1-3 of the M-ARRM theoretical model.

The investigators are supported in these efforts through partnerships in both Boston, MA and Columbia SC, the sites for the randomized controlled trial. Participating partners include those providing commercialization support (Global Protection Corp, USC Columbia Incubator, SC Launch, Moker CPCA), recruitment and marketing support in Boston (New England Association of HIV over 50, Massachusetts Department of Public Health Statewide Consumer Advisory Board on HIV/AIDS, Brigham & Women's Hospital Women's Health Center) and in Columbia (South Carolina Lieutenant Governor's Office on Aging, South Carolina HIV/AIDS Council, AID Upstate in South Carolina, Lowcountry AIDS Services, United Way Association of South Carolina, South Carolina Primary Care Association, Columbia Housing Authority in South Carolina, Palmetto AIDS Life Support Services), and content and technology development and support (University of South Carolina College of Social Work and Department of Computer Science and Engineering, South Carolina HIV/AIDS Council)

Conditions

Hiv; Sexually Transmitted Diseases; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

control

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

Group Type: ACTIVE_COMPARATOR

written materials on safe sex

Intervention Type: OTHER

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

intervention

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

Group Type: EXPERIMENTAL

safe sex and HIV/STD prevention education via a website

Intervention Type: 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.

Interventions

safe sex and HIV/STD prevention education via a website

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 Type: BEHAVIORAL

written materials on safe sex

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• divorced or separated women
• 50 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

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Environment and Health Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Patricia Weitzman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Environment and Health Group

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

R44AG034707

Identifier Type: NIH

Identifier Source: org_study_id

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