Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men
Condition: Human Immunodeficiency Virus (HIV); Sexually Transmitted Disease (STD)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      African American men have by far the highest rates of HIV in the US, but there are few
      randomized controlled trials (RCTs) of interventions to dissuade heterosexually active
      African American men from engaging sexual risk behavior. This research seeks to address this
      gap in the behavioral intervention literature. That self-initiated behavior change, as well
      as intervention-induced behavior change, is often short-lived, eroding over time, is widely
      known; accordingly, this research also seeks to test a strategy to sustain intervention
      efficacy. In a RCT, African American men 18 to 45 years reporting recent unprotected
      intercourse with a woman will be randomized to the Steering Together in a New Direction
      (STAND) HIV Risk Reduction Intervention or a No-Intervention Control Condition. To test a
      strategy to sustain intervention effects, the men also will be randomized to receive or not
      receive individually tailored text messages. The theoretical basis of the interventions is
      social cognitive theory and the reasoned action approach, which is an extension of the theory
      of planned behavior and the theory of reasoned action. Men will complete self-report measures
      via audio computer-assisted self-interviewing at baseline and immediately post and 6 and 12
      months post-intervention. The trial will test whether the STAND HIV Risk Reduction
      Intervention as compared with the No-Intervention Control Condition, increases consistent
      condom use, the primary outcome. Secondary outcomes include unprotected intercourse, multiple
      sexual partners, insertive anal intercourse, and proportion condom-protected intercourse. The
      trial will also test whether STAND's efficacy is greater among men in the Text Messaging
      Intervention compared with men not receiving text messages. This will provide information on
      the utility of a low-cost strategy to extend an intervention's efficacy. Finally, the study
      will test for mediation of intervention effects: the hypothesis that STAND affects outcome
      expectancies and self-efficacy, which, in turn, affect consistent condom use.
    

Detailed description: 
      HIV/AIDS has had a devastating impact on African Americans, who have the highest rates of
      HIV/AIDS as compared with Whites, Hispanics, Asians, and Native Americans. Although African
      Americans comprise only 13% of the US population, more than 40% of people living with
      HIV/AIDS in the US are African American-some 192,277 people. New diagnoses of HIV/AIDS
      underscore the epidemic's impact on African Americans. Almost 50% of the people newly
      diagnosed with HIV/AIDS in the 33 states with confidential name-based HIV infection reporting
      in 2006 were African Americans. The overall rate of newly diagnosed cases was 19 cases per
      100,000, but among African Americans, it was 68 per 100,000. The estimated rates of HIV/AIDS
      in 2006 were higher among African American men (121 per 100,000) as compared with White men
      (17 per 100,000), Latino/Hispanic men (51 per 100,000), and African American women (57 per
      100,000). Heterosexual exposure is a key HIV transmission category among African Americans.
      To be sure, the largest number of estimated cases of HIV/AIDS among African American men fell
      in the men who have sex with men (MSM) HIV-transmission category. However, the second largest
      number of cases was attributed to heterosexual transmission, with the injection-drug-use
      HIV-transmission category ranking third. Moreover, heterosexual exposure was a more important
      HIV-transmission category among African American men than among other men. It accounted for
      23% of HIV/AIDS cases among African American men, but 19% among Hispanic men and only 7% of
      cases among White men. Furthermore, among African American women, who comprised over 60% of
      the women with HIV/AIDS in 2006, heterosexual exposure was by far the most important
      transmission category, accounting for 83% of cases. Heterosexual exposure is especially
      important in Philadelphia, Pennsylvania, where the proposed study will be conducted.
      According to the Philadelphia Department of Public Health, among African American men,
      heterosexual exposure surpassed male-to-male contact as the modal exposure category in 2006,
      2007, and 2008.

      Furthermore, another important health disparity affecting African Americans particularly in
      urban areas is the high rate of sexually transmitted disease (STD). About 47% of the cases of
      Chlamydia trachomatis (CT) reported to Centers for Disease Control and Prevention (CDC) in
      2006 occurred in African Americans. The CT rate was 7 times higher among African American
      women than among White women. The Neisseria gonorrhea rate was 25 times higher among African
      American men than among White men and 14 times higher among African American women than among
      their White counterparts. Despite the high rate of heterosexual exposure to HIV and the high
      rates of other STDs in African American men and women, little research has focused on
      interventions targeting heterosexually active men.

      Sexual Risk Behavior among Heterosexually Active African American Men

      Two key behaviors that increase risk of STD, including HIV, are failing to use condom
      consistently and having multiple sexual partners. Although unmarried African American men
      were more likely to report consistent condom use than were their Hispanic or White
      counterparts, which may reflect recognition of higher risk of STD among African American men,
      a large percentage of African American men (47%) risked exposure to HIV and other STDs.
      Moreover, consistent condom use declined substantially with increasing age, from 68% in those
      15 to 19 years of age, to 31% in those 25 to 29 years of age, and to only 26% in those 40 to
      44 years of age. In the National Survey of Family Growth, among men 15-44 years of age,
      unmarried African American men were more likely to have had 4 or more partners in the past
      year (13%) compared with White (6%) and Hispanic men (7%).

      Interventions to Reduce Risk of Heterosexual Transmission of HIV in African American Men

      Whether one considers the domestic or international literature, few randomized controlled
      trials (RCTs) of interventions have focused on risk of heterosexual transmission of HIV among
      men. Of particular concern is the paucity of trials on the efficacy of risk-reduction
      interventions specifically targeting African American men. A systematic review of HIV/STD
      risk-reduction interventions found that only 12 of 1157 intervention studies worldwide were
      conducted on males only, and only 4 focused exclusively on African American adult men. A more
      recent review of interventions to reduce heterosexual transmission of HIV among African
      Americans identified 38 RCTs, but only 7 targeted males only and 2 of the 7 focused on
      adolescent boys. Thus, only 5 of the 38 trials focused specifically on African American men.
      Combining the studies identified in these 2 reviews yields only 6 trials specifically on
      heterosexual transmission among African American adult men and only 1 focused on the general
      population of heterosexual men. A recent clinic-based study on 266 African American men 18 to
      29 years of age diagnosed with an STD is more encouraging. At 3-month follow-up, those
      randomized to a single session one-on-one intervention reported fewer unprotected sex acts
      than did those who received standard clinical care. In addition, medical-records review
      revealed that the intervention participants were less likely to acquire a new STD by 6 months
      post-intervention than were the control men. Although the few existing studies are an
      important first step in beginning to develop interventions for African American men, there is
      still an important gap in the literature as noted by Seal and Ehrhardt who asserted that
      heterosexual men's sexual and reproductive health is often exclusively viewed in the context
      of their female partners. They called for interventions that focus on men's health and
      consider men's heterosexual behavior as a starting point in intervention development.

      Sustaining Intervention-Induced Behavior Change

      As evidence accumulates for the benefits of behavioral interventions it is also clear that
      often the effects are short lived. The present study will test the efficacy of a relatively
      inexpensive strategy to sustain behavior change. Many strategies have been employed. The
      inclusion of booster sessions in intervention programs has been suggested as a strategy to
      extend their effects, a strategy consistent with relapse prevention approaches that have been
      employed in substance-abuse reduction and smoking cessation programs. Several HIV
      risk-reduction intervention studies have incorporated boosters in their interventions, but
      the existing studies do not provide clear evidence for the efficacy of boosters per se,
      because they were not designed to compare the effects of an HIV/STD risk-reduction
      intervention with a booster to the effects of that same intervention without the booster. In
      addition to booster sessions, there may be other effective methods for extending intervention
      effects. Telephone counseling programs have been shown to help smokers who are in the process
      of quitting. Periodic mailings have also been found to be more effective than a telephone hot
      line in preventing relapse among former cigarette smokers.

      This study will test whether text messages extend an HIV risk-reduction intervention's
      efficacy. The use of text messaging has several advantages. It is relatively inexpensive,
      possibly even more cost effective than other phone or print-based interventions. Participants
      do not have to return for another intervention session, facilitators do not have to conduct
      the sessions, and no space must be made available. Text messages are delivered almost
      immediately and can be stored in the recipient's phone, accessible at a time that suits him.
      Tailored messages are more efficacious than are messages that are not tailored, and text
      messages can be individually tailored to promote condom use to men who fail to use them for
      different reasons. Pew surveys reveal that a great majority of African Americans own cell
      phones, African Americans are more intense and frequent users of all the phones' capabilities
      than are Whites, and more African Americans than Whites use text messaging. Although RCTs of
      text-messaging interventions have reported significant effects on healthful behaviors,
      including reduced cigarette smoking, increased adherence to insulin regimens in diabetics,
      and increased medical appointment keeping, no trials have examined whether text messaging can
      enhance the efficacy of an HIV risk-reduction intervention.

      The study will utilize a RCT design. Participants will be recruited through advertising in a
      local free newspaper, through community based organizations that serve African Americans,
      through recruitment flyers at universities, bars, health clubs, and health fairs, and through
      face-to-face recruitment at social and sports events and activities expecting a high turnout
      of African American men. Computer-generated random number sequences will be used to randomize
      them to the Steering Together in a New Direction (STAND) HIV Risk Reduction Intervention or a
      No-Intervention Control Condition and to receive or not receive a Text Messaging
      Intervention. Participants will complete assessments via audio computer-assisted
      self-interviewing before the intervention and immediately post and 6 and 12 months
      post-intervention administered by data collectors blind to the participants randomly assigned
      condition. The trial will test whether the STAND intervention increases the consistent use of
      condoms and decreases other sexual risk behaviors compared with the no-intervention control
      group, whether the text messages are efficacious, and whether the efficacy of the STAND
      intervention is enhanced among men who receive the text messages.
    

Intervention name(s): STAND HIV Risk Reduction Intervention; Text Messaging Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-minute sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.; Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.
Other intervention name(s): HIV Risk Reduction Intervention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human immunodeficiency virus; Sexually transmitted disease; Behavioral intervention; Randomized controlled trial; Text messages; Social cognitive theory; Theory of planned behavior; Sexual behavior; African Americans; Men