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| ID | Type | Description | Link |
|---|---|---|---|
| U65/CCU424514-02 | Other Grant/Funding Number | CDC Cooperative Agreement U65/CCU424514 |
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| Name | Class |
|---|---|
| SisterLove, Inc. | OTHER_GOV |
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The purpose of this program evaluation is to determine whether the Health Love Workshop, a group-level HIV behavioral intervention, reduces HIV-related sex risk behaviors and increases HIV protective behaviors of African American women and women of African descent. The intent of this program is to support an evaluation of the efficacy of the intervention and to provide feedback to the implementing organization to increase intervention effectiveness.
SisterLove, Inc. in Atlanta, Georgia, is evaluating its HIV/AIDS prevention intervention called the Healthy Love Workshop (HLW). The HLW targets African American women and women of African descent who are at risk for HIV infection and transmission. The HLW, which lasts 3 to 4 hours and is delivered during a single session, is a highly interactive workshop that aims to provide a safe environment in which women can learn about: a) the modes of HIV transmission, b) effective strategies for reducing one's risk for contracting or transmitting HIV or other STIs, c) opportunities to develop or enhance skills for self-assessing the risk level of sexual behaviors and the use of safer sex techniques, and d) how to develop an awareness of personal, community and social attitudes, beliefs and norms that influence women's relationships, sexual behavior, and decision-making. SisterLove will identify a minimum of 28 groups of women to participate in the evaluation, which will use a concurrent comparison design with block randomization. These groups will be typical of those that currently receive the HLW, including but not limited to sororities, friendship circles, church groups and other affinity-based groups. Fourteen of the 28 groups will participate in HLW as the intervention group; 14 of the recruited groups will participate in an HIV/AIDS 101 workshop (HIV 101) as the comparison group. Each group will contain about 15 women, thus approximately 420 women will participate in the evaluation. Outcome measures will assess HIV/AIDS knowledge, attitudes towards condom use and HIV testing, condom use intentions, personal HIV/AIDS risk assessment, self-efficacy for taking steps to prevent HIV transmission, consistent condom use, sexual abstinence, and reduction in other sexual risk behaviors. These outcomes will be measured at baseline, and after the intervention at 3- and 6-month follow-ups.
Eligible groups of women were randomly assigned to receive the intervention (15 groups; 161 women) or a comparison workshop (15 groups; 152 women). Behavioral assessments were conducted at baseline and at 3- and 6-month follow-ups. Among sexually active women at the 3-month follow-up, HLW participants were more likely than comparison participants to report having used condoms during vaginal sex with any male partner or with a primary male partner, and to have used condoms at last vaginal, anal or oral sex with any male partner. At the 6-month follow-up, HLW participants were more likely to report condom use at last vaginal, anal or oral sex with any male partner, and having an HIV test and receiving their test results. The study findings suggest that a single-session intervention delivered to pre-existing groups of black women is an efficacious approach to HIV prevention. This study also demonstrates that a CBO can develop and deliver a culturally appropriate, effective HIV prevention intervention for the population it serves and, with adequate resources and technical assistance, rigorously evaluate its intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Love Workshop | Experimental | Single-session, small-group HIV prevention intervention |
|
| HIV101 | Active Comparator | Single-session, small-group intervention providing facts regarding HIV/AIDS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Love Workshop | Behavioral | The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results. |
| Measure | Description | Time Frame |
|---|---|---|
| Condom Use During Vaginal Sex With Any Male Partner | Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months | Past 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Testing and Receipt of Results | Percentage of women who reported testing for HIV infection and received their test results during the past 3 months | Past 3 months |
| HIV Knowledge | current |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Abstinence | The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners | Past 3 months |
| Unprotected Vaginal Sex With Any Male Partner | The percentage of women who engaged in unprotected vaginal sex (i.e., did not use a condom) with any male partner during the past 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dazon Dixon Diallo, MPH | President/CEO SisterLove, Inc. | Principal Investigator |
| Jeffrey H Herbst, PhD | Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC | Study Director |
| Thomas M Painter, PhD | Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SisterLove, Inc. | Atlanta | Georgia | 30331 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20135214 | Result | Diallo DD, Moore TW, Ngalame PM, White LD, Herbst JH, Painter TM. Efficacy of a single-session HIV prevention intervention for black women: a group randomized controlled trial. AIDS Behav. 2010 Jun;14(3):518-29. doi: 10.1007/s10461-010-9672-5. | |
| 24743662 | Derived | Painter TM, Herbst JH, Diallo DD, White LD; Centers for Disease Control and Prevention (CDC). Community-based program to prevent HIV/STD infection among heterosexual black women. MMWR Suppl. 2014 Apr 18;63(1):15-20. |
| Label | URL |
|---|---|
| SisterLove, Inc. | View source |
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28 groups did not participate for logistical reasons, including lack of follow-up by group contact (10 groups), failure of women to arrive for the workshop (7 groups), and too few women to meet minimum workshop size (6 groups). Five groups did not participate because of insufficient interest by their members in receiving either workshop.
Information about the study was disseminated through print media, public service announcements on local radio stations, electronic communication and informational mailings to local AIDS service organizations, county health departments, medical clinics, and community centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Love Workshop | The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results. |
| FG001 | HIV101 | The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Love Workshop | The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Condom Use During Vaginal Sex With Any Male Partner | Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months | Women who were sexually active at 3-month follow-up and who provided data on outcome measure | Posted | Mar 2010 | Number | Percent | Past 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Love Workshop | The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dazon Dixon-Diallo, Executive Director | SisterLove, Inc. | 404-505-7777 | ddiallo@sisterlove.org |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| D012309 | Risk-Taking |
| D021841 | Safe Sex |
| D012725 | Sexual Behavior |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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|
|
| HIV/AIDS 101 Workshop | Behavioral | The comparison workshop (named HIV101) was also delivered as a single session lasting 2-3 h, to groups of women about the same size and in settings similar to those used for the HLW. The HIV101 workshop consists of an opening, one module containing the same three HIV/STD-related components as the HLW (HIV/AIDS facts, STI facts, and the Look of HIV) and a closing. However, the presentation of this information used a didactic, lecture-style format, as opposed to the interactive approach used to deliver the HLW. |
|
|
| Condom Use Self-efficacy | current |
| Knowledge of HIV Test | current |
| Past 3 months |
| Number of Male Sex Partners | The number of male sex partners during the past 3 months | Past 3 months |
| BG001 | HIV101 | The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| HIV101 |
The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections. |
|
|
|
| Other Pre-specified | Sexual Abstinence | The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners | Based on the number of women who provided valid data at the 3-month follow-up | Posted | Mar 2010 | Number | Percent | Past 3 months |
|
|
|
|
| Other Pre-specified | Unprotected Vaginal Sex With Any Male Partner | The percentage of women who engaged in unprotected vaginal sex (i.e., did not use a condom) with any male partner during the past 3 months | Based on the number of women who provided valid data at the 3-month follow-up | Posted | Mar 2010 | Number | Percent | Past 3 months |
|
|
|
|
| Other Pre-specified | Number of Male Sex Partners | The number of male sex partners during the past 3 months | Based on the number of women who provided valid data at the 3-month follow-up | Posted | Mar 2010 | Mean | Standard Deviation | Number of sex partners | Past 3 months |
|
|
|
|
| Secondary | HIV Testing and Receipt of Results | Percentage of women who reported testing for HIV infection and received their test results during the past 3 months | Based on the number of women who provided data at the 3-month follow-up | Posted | Mar 2010 | Number | Percent | Past 3 months |
|
|
|
|
| Secondary | HIV Knowledge | Not Posted | current |
| Secondary | Condom Use Self-efficacy | Not Posted | current |
| Secondary | Knowledge of HIV Test | Not Posted | current |
| 0 |
| 161 |
| 0 |
| 161 |
| EG001 | HIV101 | The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections. | 0 | 152 | 0 | 152 |
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| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |