HIV Infections, Sexually Transmitted Infections
Conditions
Keywords
Adult, *HIV Infections/pc [Prevention & Control], Female, Humans, Risk-Taking, Safe Sex, Sexual Behavior, HIV Testing
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* Women of African descent (including African Americans, Caribbean, and African Immigrants) * Over the age of 18 years
Exclusion criteria
* Women who are pregnant or planning to become pregnant * Do not speak English * Recent (past 6 months) participation in HIV prevention workshop
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Condom Use During Vaginal Sex With Any Male Partner | Past 3 months | Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Condom Use Self-efficacy | current | — |
| Knowledge of HIV Test | current | — |
| HIV Knowledge | current | — |
| HIV Testing and Receipt of Results | Past 3 months | Percentage of women who reported testing for HIV infection and received their test results during the past 3 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Male Sex Partners | Past 3 months | The number of male sex partners during the past 3 months |
| Sexual Abstinence | Past 3 months | The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners |
| Unprotected Vaginal Sex With Any Male Partner | Past 3 months | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 161 |
| 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. | 152 |
| Total | 313 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 40 | 35 |
Baseline characteristics
| Characteristic | Healthy Love Workshop | HIV101 | Total |
|---|---|---|---|
| Age Continuous | 29.1 years STANDARD_DEVIATION 10.1 | 33.7 years STANDARD_DEVIATION 12.7 | 31.3 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 161 participants | 152 participants | 313 participants |
| Sex: Female, Male Female | 161 Participants | 152 Participants | 313 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 161 | 0 / 152 |
| serious Total, serious adverse events | 0 / 161 | 0 / 152 |
Outcome results
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
Time frame: Past 3 months
Population: Women who were sexually active at 3-month follow-up and who provided data on outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Love Workshop | Condom Use During Vaginal Sex With Any Male Partner | 59.3 Percent |
| HIV101 | Condom Use During Vaginal Sex With Any Male Partner | 39.6 Percent |
Condom Use Self-efficacy
Time frame: current
HIV Knowledge
Time frame: current
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
Time frame: Past 3 months
Population: Based on the number of women who provided data at the 3-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Love Workshop | HIV Testing and Receipt of Results | 20.2 Percent |
| HIV101 | HIV Testing and Receipt of Results | 16.3 Percent |
Knowledge of HIV Test
Time frame: current
Number of Male Sex Partners
The number of male sex partners during the past 3 months
Time frame: Past 3 months
Population: Based on the number of women who provided valid data at the 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Love Workshop | Number of Male Sex Partners | 0.70 Number of sex partners | Standard Deviation 0.6 |
| HIV101 | Number of Male Sex Partners | 0.67 Number of sex partners | Standard Deviation 0.74 |
Sexual Abstinence
The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners
Time frame: Past 3 months
Population: Based on the number of women who provided valid data at the 3-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Love Workshop | Sexual Abstinence | 36.6 Percent |
| HIV101 | Sexual Abstinence | 43.6 Percent |
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
Time frame: Past 3 months
Population: Based on the number of women who provided valid data at the 3-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Love Workshop | Unprotected Vaginal Sex With Any Male Partner | 37.6 Percent |
| HIV101 | Unprotected Vaginal Sex With Any Male Partner | 36.2 Percent |