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临床试验/NCT00644163
NCT00644163已完成不适用

NIMH Multisite HIV/STD Prevention Trial for African American Couples

University of Pennsylvania7 个研究点 分布在 1 个国家目标入组 1,070 人开始时间: 2003年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,070
试验地点
7
主要终点
Occurrence of STDs (chlamydia, gonorrhea, and trichomonas)

研究概览

简要总结

This study will evaluate the effectiveness of a risk-reduction program in preventing the transmission of HIV and sexually transmitted diseases among African-American heterosexual couples, with one partner having been previously diagnosed with an HIV infection.

详细描述

The transmission of sexually transmitted diseases (STDs), including HIV, is a major public health concern, especially among minority groups in the United States. Although STDs are prevalent across all racial and ethnic groups in the United States, the rate of STD infection is disproportionately higher for African Americans than for white Americans. African Americans have higher rates of HIV, chlamydia, gonorrhea, syphilis, and herpes than white Americans. An important part of the prevention process is early education on HIV to reduce sexual-risk behavior and to promote safe sexual practices. Interventions are needed in a variety of settings to extensively address African Americans' risk of STDs, including HIV. Although most HIV/STD risk-reduction interventions are conducted at the individual level, a couple-based approach may be more effective and consistent with cultural values. This study will compare the effectiveness of the Eban HIV/STD Risk Reduction Intervention with the Eban Health Promotion Intervention in reducing the risk of STDs among African-American HIV-serodiscordant heterosexual couples.

Participation in this study will last 12 months. All participants will first undergo baseline assessments that will consist of questionnaires and biospecimen collection for STD testing. Participants will then be assigned randomly to one of two treatment groups: the Eban HIV/STD Risk Reduction Intervention group or the Eban Health Promotion Intervention group. Both groups will participate in weekly 2-hour sessions over 8 weeks. The sessions will include couple and group sessions led by trained male and female co-facilitators. The Eban HIV/STD Risk Reduction Intervention sessions will focus on the couple and will teach the couple about communication skills. The approach will draw upon social cognitive theory, an ecological framework, and HIV/STD risk-reduction research with inner-city African-American populations. The Eban Health Promotion Intervention sessions will focus on the individual and will provide factual information on health, screening, exercise, diet management, and medication adherence. Follow-up visits for all participants will occur at Months 3, 6, and 12 and will include repeat baseline assessments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Each partner agrees that the relationship has lasted at least 6 months before study entry
  • Each partner intends to remain together for at least 12 months after study entry (e.g., state independently that he/she is confident or very confident that they will remain together)
  • At least one partner of the couple reports having unprotected intercourse at least once in the 90 days before study entry
  • Neither partner has plans to relocate beyond a reasonable distance from the study site
  • At least one partner is African American
  • At least one partner agrees that he/she is not planning pregnancy within the next 18 months after study entry
  • Each partner is aware of his/her partner's HIV serostatus
  • Only one partner is HIV seropositive and has known his or her status for at least 3 months before study entry

排除标准

  • One or both partners do not have an address where they can receive mail
  • One or both partners have significant psychiatric, physical, or neurological impairment that would limit their effective participation as confirmed on a Mini Mental State Examination and/or Quick Test
  • History of severe physical or sexual abuse in the 1 year before study entry in the current relationship (e.g., significant enough to require medical, psychological, and/or legal intervention)
  • One or both partners are unwilling or unable to commit to participate in the study through to completion
  • Both partners have previously participated in an HIV sexual risk-reduction intervention for couples in the 12 months before study entry
  • One or both partners are not fluent in English as determined by the informed consent process

研究组 & 干预措施

1

Experimental

Participants will receive Eban HIV/STD Risk Reduction Intervention.

干预措施: Eban HIV/STD Risk Reduction Intervention (Behavioral)

2

Active Comparator

Participants will receive Eban Health Promotion Intervention.

干预措施: Eban Health Promotion Intervention (Behavioral)

结局指标

主要结局

Occurrence of STDs (chlamydia, gonorrhea, and trichomonas)

时间窗: Measured at Month 12

Self-reported proportion of condom-protected sexual intercourse

时间窗: Measured at Month 12

次要结局

  • Number of sexual partners(Measured at Month 12)
  • Unprotected sex occurrence(Measured at Month 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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