Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062634
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-06-09
Brief Title:
Education Program to Promote Female Condom Use
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Female Condom Intervention Trial
Status:
UNKNOWN
Status Verified Date:
2004-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The female condom offers women a potentially important option for HIV prevention This study will develop and evaluate a health education program to increase female condom use among ethnically diverse women
Detailed Description:
AIDS incidence among women has grown at alarming rates since 1985 Heterosexual contact is now the greatest risk for HIV infection in women Women in the United States urgently need more options to protect themselves against HIV Nonetheless limited prevention efforts have targeted women The female condom is a potentially important option for HIV prevention in women However little research has been conducted to identify effective approaches to promote the female condom as the only female-controlled barrier method available to date This study will develop a theoretically and empirically based intervention to increase female condom use among ethnically diverse women who engage in multiple sexual partnerships
The proposed female condom skills training intervention applies social cognitive theory It also incorporates our extensive previous research that examined female condom acceptability and identified the attitudinal interpersonal and sociocultural factors affecting female condom use The intervention consists of four sessions 1 individual safer sex education and condom use skills training 2 group discussion of barriers to female condom use 3 group condom negotiation skills training and 4 individual condom use counseling The efficacy of the intervention will be assessed by comparing it to a control condition intervention that focuses on womens general health issues unrelated to HIVAIDS The control condition intervention has four sessions 1 individual health education 2 group discussion of womens health problems and related risk behaviors 3 group discussion of healthy living and 4 individual health risk reduction counseling
This study will use a randomized clinical trial design Study participants will be randomly assigned to one of two conditions female condom skills training or womens general health promotion All participants will be interviewed at study entry 3 months and 6 months Attitudinal psychosexual and behavioral data will be collected to evaluate the intervention
The proposed female condom skills training intervention applies social cognitive theory It also incorporates our extensive previous research that examined female condom acceptability and identified the attitudinal interpersonal and sociocultural factors affecting female condom use The intervention consists of four sessions 1 individual safer sex education and condom use skills training 2 group discussion of barriers to female condom use 3 group condom negotiation skills training and 4 individual condom use counseling The efficacy of the intervention will be assessed by comparing it to a control condition intervention that focuses on womens general health issues unrelated to HIVAIDS The control condition intervention has four sessions 1 individual health education 2 group discussion of womens health problems and related risk behaviors 3 group discussion of healthy living and 4 individual health risk reduction counseling
This study will use a randomized clinical trial design Study participants will be randomly assigned to one of two conditions female condom skills training or womens general health promotion All participants will be interviewed at study entry 3 months and 6 months Attitudinal psychosexual and behavioral data will be collected to evaluate the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None