Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men
Condition: Human Immunodeficiency Virus Infection; Sexually Transmitted Diseases
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      Sub-Saharan Africa has about 10% of the world's population, but was home to more than 60% of
      all people living with HIV in 2003. South Africa continues to have the largest number of
      people living with HIV in the world, and as in other parts of sub-Saharan Africa,
      heterosexual exposure is the primary HIV transmission category. Worldwide, efforts to stem
      the spread of HIV among heterosexuals have stressed the impact of HIV on women. Oft-cited
      statistics indicate that about half of all people living with HIV are women. The strategies
      typically offered to address the impact of HIV on women are interventions with women. An
      alternative approach to addressing women's risk of heterosexual transmission of HIV, one that
      would be an important complement to the predominant approach, is focusing on men. By reducing
      sexual risk behavior of men, it should be possible to reduce rates of HIV in both men and
      women. The rates in men would decline because they are the recipients of the intervention;
      rates in women would decline because they have sex with men. Interventions aimed at men could
      take into account the power that men have in sexual decision-making and risk taking. However,
      whether one considers the US literature or the international literature, few randomized
      controlled trials of HIV/STD risk-reduction interventions have focused on heterosexual men.
      Accordingly, the purpose of this research is to develop and test the efficacy of an
      intervention to curb HIV/STD risk-associated behavior in South African men who have sex with
      women. A cluster-randomized controlled trial design will be used to reduce the potential for
      contamination between treatment arms that would be present if individuals were randomized. An
      attention control group will be used to control for Hawthorne effects, special attention, and
      group interaction. Matched pairs of neighborhoods in Black townships in Eastern Cape
      Province, South Africa similar on key characteristics will be created, 22 pairs will be
      randomly selected, and men will be recruited. One neighborhood in each pair will be randomly
      assigned to each of the 2 study arms. We hypothesized that men who receive a culturally
      appropriate theory-based HIV/STD risk-reduction intervention will be more likely to report
      consistently using condoms during intercourse in the 12-month post intervention period than
      will men who receive an attention-control intervention, adjusting for baseline condom use.
    

Detailed description: 
      Sub-Saharan Africa has just over 10% of the world's population, but according to UNAIDS was
      home to more than 60% of all people living with HIV in 2003-some 25.4 million people. South
      Africa continues to have the largest number of people living with HIV in the world. As in
      other parts of sub-Saharan Africa, heterosexual exposure is the primary HIV transmission
      category. An estimated 5.3 million South Africans-2.9 million women and 2.4 million men-were
      living with HIV at the end of 2003.

      Worldwide, efforts to stem the spread of HIV among heterosexuals have stressed the impact of
      HIV on women. Oft-cited statistics indicate that about half of all people living with HIV are
      women. It is often suggested that women are seldom free to make empowered choices and face a
      range of HIV-related vulnerabilities that men do not face-many of which are embedded in the
      social relations and economic realities of their societies. Women's economic dependence on
      their male partners and the fact that women do not have the power to abstain from sex or to
      insist on condom use-even when they suspect that their man has other sexual partners and
      might have HIV-is emphasized. The hazards of young women's sexual relationships with older
      men and the high rate of rape and other forms of sexual coercion are cited. Men are typically
      mentioned as injection drug users, as having sex with other men-whether as MSMs or being on
      the "down low"-or as being the cause of the spread of HIV in women. The strategies typically
      offered to address the impact of HIV on women are interventions with women. For instance, it
      is recommended that women be taught the information and skills to make decisions about the
      terms of their sexual relationships, that methods of protection that women can control (e.g.,
      microbicides) be developed, and that boosting women's economic opportunities and social power
      should be seen as part and parcel of potentially successful and sustainable HIV prevention
      strategies.

      To be sure, there is an alternative approach to addressing women's risk of heterosexual
      transmission of HIV, one that would be important complement to the predominant approach:
      namely, focusing on men. Although it is noted that HIV is affecting women most severely in
      places where heterosexual exposure is a dominant mode of transmission, this seldom leads to a
      recommendation that interventions be developed to change men's behavior. Yet, by reducing
      men's sexual risk behavior, it should be possible to reduce rates of HIV in both men and
      women. Men's rates would decline because they are the recipients of the intervention; women's
      rates would decline because they have sex with men. Interventions targeting men could take
      into account the power that men have in sexual decision-making and risk taking.

      However, whether one considers the US literature or the international literature, few
      randomized controlled trials (RCTs) of HIV/STD risk-reduction interventions have targeted
      heterosexual men. Elwy and colleagues 2002 review of HIV/STD prevention intervention studies
      revealed that only 12 of 1157 studies worldwide were conducted on males only. Most were not
      RCTs demonstrating intervention efficacy. Only 2 demonstrated significant effects on
      mediators and behaviors, and neither was a RCT. In addition, scant attention has focused on
      the general population of heterosexual men in any region. Indeed, 8 of the 12 studies focused
      on incarcerated men, STD patients, substance abusers, miners, or truck drivers. To address
      this gap in the literature, the proposed trial will focus on men who are more representative
      of the general population. In many developing countries, including South Africa, the HIV/AIDS
      epidemic is generalized, and there is a need to develop and test interventions for a broad
      range of the population, not just special high-risk sub-populations.

      Accordingly, the purpose of this research is to develop and test the efficacy of an
      intervention to reduce behaviors that create the risk for contracting and transmitting STD,
      including HIV, among South African men who have sex with women. A cluster-randomized control
      trial design will be used to reduce the potential for contamination between treatment arms
      that would be present if individuals were randomized. An attention control group will be used
      to control for Hawthorne effects, special attention, and group interaction. Men will be
      recruited from Black townships surrounding East London, including Mdantsane, Scenery Park,
      Duncan, Village, and Gompo Town, and the semi-rural area of Berlin in the Eastern Cape
      Province of South Africa. More than 98% of the residents of these areas are Black Africans,
      and isiXhosa is the first language for 98.8% of the population. There are 206 neighborhoods
      defined as geographical clusters tied to census data in this catchment area, allowing the
      creation of 103 matched pairs of neighborhoods similar on the percentage isiXhosa-speaking,
      percentage married, percentage male, percentage living in informal dwellings, percentage
      unemployed, and population size. From the 103 matched pairs, 22 pairs will be randomly
      selected for the trial. One neighborhood in each pair will be randomly assigned to each of
      the 2 study arms.

      Before recruiting from a neighborhood, meetings with community leaders (e.g., councilor,
      clergy) will be held to enlist their support. In addition, a meeting will be held to inform
      men in the neighborhood about the study. Recruiters will inform potential participants about
      the study, obtain consent to be screened, and conduct a brief screening interview to
      determine eligibility and willingness to participate. Eligible men will be invited to
      participate in the "Men, Together Making A Difference Project" designed to understand men's
      behaviors that may create health risks such as heart disease, cancer, and STDs, especially
      HIV, and to find ways to teach men how to reduce these risks. A common participant
      recruitment and enrollment protocol, including use of the same posters and other materials,
      will be followed in the neighborhoods in both conditions. Eligible men will be recruited in
      advance of randomization so that at the time they agree to participate they will be blind to
      the specific intervention they will receive. This procedure will reduce the probability of
      self-selection bias into the different conditions of the trial.

      All participants will complete self-report measures via audio computer-assisted
      self-interviewing before the intervention, immediately after, and 6 and 12 months after the
      intervention. Several steps will be taken to increase the validity of self-report measures.
      Participants will be given a calendar, with the dates clearly marked. This will make salient
      to respondents the dates that are included when they are asked to recall their behavior "in
      the past 3 months" and that they should be specific. The importance of responding honestly
      will be emphasized. They will be informed that their responses will be used to create
      programs for South African men like themselves and that this will be possible only if they
      answer the questions honestly. This pits the social responsibility motive against the social
      desirability motive. Participants will be assured that their responses will be kept
      confidential. Facilitators who lead the intervention groups will not be involved in any way
      in the data collection. The use of ACASI should also serve to increase participants'
      motivation to respond accurately.

      There are 2 Specific Aims. Aim 1 is to test the primary hypothesis that men who receive a
      culturally appropriate theory-based HIV/STD risk-reduction intervention will be more likely
      to report consistently using condoms during vaginal intercourse in the 12-month post
      intervention period than will men who receive an attention-control intervention. Aim 2 is to
      test the secondary hypothesis that outcome expectancies and self-efficacy to use condoms
      mediate the HIV/STD risk-reduction intervention's effect on condom use. In addition, an
      exploratory aim is to conduct hypothesis-generating analyses on whether the efficacy of the
      intervention varies depending on neighborhood characteristics or participants' baseline
      characteristics. The effects of HIV/STD risk-reduction interventions may differ as a function
      of the neighborhood's unemployment rate, percentage living in informal dwellings/shacks,
      percentage married, or sex ratio. Potential individual-level moderators include age, marital
      status, language use (English versus isiXhosa), and alcohol and drug use.

      The unit of inference in this trial is the individual. This is because the trial is designed
      to test the efficacy of a behavior-change intervention based on individual-level behavior
      change theory. As Donner and Klar in 2000 noted in their influential textbook on
      cluster-randomized trial, the unit of inference, not the unit of randomization, determines
      the unit of analysis.

      The data will be analyzed using an intention-to-treat mode, with participants analyzed based
      on their intervention assignment, regardless of the number of intervention or data-collection
      sessions attended. The primary aim focuses on testing for significant differences between two
      treatment conditions over the post intervention period. Major statistical challenges arise in
      the proper handling of repeated clustered outcomes. Each variable of interest is completed by
      each man, nested within a neighborhood, thus creating a correlated outcome. Moreover, the
      multiple assessments of each variable over the study period produce correlated repeated
      outcomes. The primary challenge in the analysis of such data is appropriate adjustments for
      the differential treatment means between clusters and the correlations among the observations
      within a cluster (cluster effects).

      Most statistical models assume stochastic independence among observations and thus are
      inappropriate for clustered data. In this trial, generalized estimating equations (GEE)
      modeling will be employed to handle the clustered data appropriately. GEE modeling avoids
      explicit modeling of the within-cluster correlations by basing statistical inferences of
      model parameters on marginalized likelihood or generalized estimating equations. Since GEE
      requires a relatively large sample size, it is not appropriate for small studies. Given the
      large sample size, GEE is appropriate for in this trial. The implementation for this trial is
      relatively straightforward. For instance, to determine whether a greater percentage of the
      men who receive the HIV/STD risk-reduction intervention report consistent condom use 6 and 12
      months post intervention, as compared with those who received the health-promotion
      intervention, the model will include time-independent covariates, baseline measure of
      consistent condom use, intervention type, and time (2 categories representing 6- and 12-month
      follow-up), which will provide the effect of the intervention over the 2 follow-up visits.

      A sample size calculation was performed to detect an a priori effect size of a 10% increase
      in consistent condom use from 32% to 42% in the HIV/STD risk-reduction intervention
      condition, adjusting for the expected variance inflation due to clustering. A 10% increase
      was selected as a clinically and substantively important effect size. Based on pilot data, an
      intraclass correlation (ICC) of 0.01 was estimated. Assuming alpha = 0.05, a 2-tailed test,
      ICC = 0.01, 15% attrition at 12-month follow-up, and N = 1,152 men in the trial from 44
      neighborhoods with an average of 26 men in each neighborhood, the trial was estimated to have
      81% power to detect a 10% increase in consistent condom use from 32% to 42% in the HIV/STD
      intervention group. Assuming the same effect size, hypothesis tests on secondary sexual
      behavior outcomes and theoretical mediator variables will have similar statistical power.
    

Intervention name(s): Men Making a Difference HIV/STD Risk Reduction Intervention; Health Promotion Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Developed based on social cognitive theory and extensive formative research, Men Together Making a Difference HIV/STD risk-reduction intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet).; The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption.
Other intervention name(s): HIV/STD Risk Reduction Intervention; Attention-Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: human immunodeficiency virus; randomized controlled trial; intervention studies; South Africa; men; sexually behavior; social cognitive theory