Quality of Research
Documents Reviewed
The documents below were reviewed for Quality of Research. The research point of
contact can provide information regarding the studies reviewed and the availability
of additional materials, including those from more recent studies that may have been conducted.
Study 1Healthy Living Project Team. (2007). Effects of a behavioral intervention to reduce risk of transmission among people living with HIV: The Healthy Living Project randomized controlled study. Journal of Acquired Immune Deficiency Syndromes, 44(2), 213-221. 
Rotheram-Borus, M. J., Desmond, K., Comulada, W. S., Arnold, E. M., Johnson, M., & the Healthy Living Trial Group. (2009). Reducing risky sexual behavior and substance use among currently and formerly homeless adults living with HIV. American Journal of Public Health, 99(6), 1100-1107.
Wong, F. L., Rotheram-Borus, M. J., Lightfoot, M., Pequegnat, W., Comulada, W. S., Cumberland, W., et al. (2008). Effects of behavioral intervention on substance use among people living with HIV: The Healthy Living Project randomized controlled study. Addiction, 103(7), 1206-1214.
Supplementary Materials Agrawal, S., Sobell, M. B., & Sobell, L. C. (2008). The Timeline Followback: A scientifically and clinically useful tool for assessing substance use. In R. F. Belli, F. P. Stafford, & D. F. Alwin (Eds.), Calendar and time diary methods in life course research (pp. 57-68). Washington, DC: Sage.
Gore-Felton, C., Rotheram-Borus, M. J., Weinhardt, L. S., Kelly, J. A., Lightfoot, M., Kirshenbaum, S. B., et al. (2005). The Healthy Living Project: An individually tailored, multidimensional intervention for HIV-infected persons. AIDS Education and Prevention, 17(1 Suppl. A), 21-39.
Gribble, J. N., Miller, H. G., Rogers, S. M., & Turner, C. F. (1999). Interview mode and measurement of sexual behaviors: Methodological issues. Journal of Sexual Research, 36, 16-24.
Kelly, J. A., Ehrhardt, A., Rotheram-Borus, M. J., & Chesney, M. (2002). NIMH Collaborative on Health-Related Interventions for People Living With HIV: Intervention quality assurance and quality control manual.
Turner, C. F., Ku, L., Rogers, S. M., Lindberg, L. D., Pleck, J. H., & Sonenstein, F. L. (1998). Adolescent sexual behavior, drug use, and violence: Increased reporting with computer survey technology. Science, 280(5365), 867-873.
Outcomes
| Outcome 1: Substance use |
|
Description of Measures
|
The substance use measure was derived from scales used in the 1999 National Survey on Drug Use and Health (NSDUH). It measured self-reported days in the past 3 months that the client used each of the following substances: alcohol, barbiturates, cocaine/crack, gamma-hydroxybutyrate (GHB), hallucinogens, heroin, inhalants, ketamine, marijuana, 3,4-methylenedioxymethamphetamine (MDMA, or ecstasy), methadone, opiates, sedatives, speedballs, steroids, and stimulants (i.e., methamphetamine/amphetamine). Interviews were conducted in private settings on laptop computers using an audio computer-assisted self-interviewing format. The TimeLine Followback (TLFB) method was used to solicit information about use of each substance. The TLFB method uses a calendar to help the respondent reconstruct prior days of drinking and drug use over a specified time period.
Reported days of use for each substance were rated on a 9-point categorical scale developed by researchers for use in this study: 0 (never), 1 (less than once per month), 3 (once per month), 7 (2-3 times per month), 12 (once per week), 30 (2-3 times per week), 60 (4-6 times per week), 90 (once per day), and 120 (more than once per day). Each substance was also assigned a severity rating according to a 5-point categorical scale developed by researchers for use in this study: 0 (none); 1 (alcohol); 2 (marijuana); 3 (barbiturates, methadone, inhalants, sedatives, and steroids); and 4 (cocaine/crack, GHB, hallucinogens, heroin, ketamine, speedballs, MDMA, opiates, and stimulants). The ratings for days of use and severity of the substance provided a weighted index for days of use by drug severity.
|
|
Key Findings
|
In a randomized clinical trial, HIV-positive clients undergoing outpatient medical care were assigned to an intervention group receiving the Healthy Living Project or to a wait-list control group. Assessments occurred at baseline and at 5-month intervals up to 25 months after randomization. Among the findings from this study were the following:
- Compared with the control group, the intervention group reported fewer days using alcohol, marijuana, methadone, inhalants, MDMA, stimulants, sedatives, barbiturates, steroids, heroin, cocaine/crack, and speedballs across the follow-up period (p < .0001).
- Compared with the control group, the intervention group reported fewer days of any substance use across the follow-up period (p < .0001).
- Among the 35% of clients who were homeless or marginally housed, those in the intervention group reported fewer days using alcohol or marijuana (p = .002) and fewer days using hard drugs (i.e., heroin, cocaine/crack, speedball, MDMA; p = .042) across the follow-up period compared with those in the control group.
- Across the follow-up period, the intervention group had greater declines than the control group in the weighted days of use by drug severity index for alcohol, marijuana, methadone, inhalants, MDMA, stimulants, sedatives, barbiturates, and steroids (p < .0001) but not for heroin, opiates, cocaine/ crack, ketamine, GHB, or hallucinogens.
- Across the follow-up period, women in the intervention group reported fewer days of substance use than women in the control group and men in either condition for alcohol, marijuana, methadone, inhalants, MDMA, stimulants, sedatives, barbiturates, steroids, heroin, cocaine/crack, and speedballs (p < .0001). Additionally, women in the intervention group had larger declines than women in the control group and men in either condition in the weighted days of use by drug severity index for all substances but heroin, cocaine/crack, and speedballs across the follow-up period (p < .0001).
- Men in the intervention group reduced their days using alcohol, marijuana, stimulants, and any substances more than men in the control group (p < .0001) and showed a larger decline in the weighted days of use by drug severity index for alcohol and marijuana (p < .0001) across the follow-up period.
- Heterosexual men in the intervention group reduced their days of stimulant use more than heterosexual men in the control group (p < .0001) and gay men in either condition (p = .03) across the follow-up period.
- Gay men in the intervention group reported fewer days of hard drug use than gay men in the control group (p < .04) and more days of hard drug use than heterosexual men in either condition (p = .0002) across the follow-up period.
|
|
Studies Measuring Outcome
|
Study 1
|
|
Study Designs
|
Experimental
|
|
Quality of Research Rating
|
3.6
(0.0-4.0 scale)
|
| Outcome 2: HIV sexual risk behaviors |
|
Description of Measures
|
HIV sexual risk behaviors were measured as the number of self-reported unprotected sexual acts in the past 3 months with a partner whose HIV serostatus was negative or unknown to the client. An unprotected sex act was defined as any act of insertive or receptive anal or vaginal intercourse in which neither party used a condom. Interviews were conducted in private settings on laptop computers using a combination of audio computer-assisted self-interviewing and computer-assisted personal interviewing.
|
|
Key Findings
|
In a randomized clinical trial, HIV-positive clients undergoing outpatient medical care were assigned to an intervention group receiving the Healthy Living Project or to a wait-list control group. Assessments occurred at baseline and at 5-month intervals up to 25 months after randomization. Among the findings from this study were the following:
- From months 5 to 25 of follow-up, the number of self-reported unprotected sexual acts steadily declined for the intervention group compared with the control group (p = .0069), after controlling for baseline group differences in the number of unprotected sexual acts.
- Clients in both conditions reported reductions in the number of unprotected sexual acts from baseline through the follow-up period (p < .0001). At the 20-month follow-up, however, intervention clients reported 36% fewer unprotected sexual acts than those in the control group (p = .007).
- Among the 35% of clients who were homeless or marginally housed, intervention clients reported fewer sexual partners who were HIV-negative or of unknown serostatus (p < .001) and fewer unprotected sexual acts (p = .037) across the follow-up period compared with control group clients.
|
|
Studies Measuring Outcome
|
Study 1
|
|
Study Designs
|
Experimental
|
|
Quality of Research Rating
|
3.8
(0.0-4.0 scale)
|
Study Populations
The following populations were identified in the studies reviewed for Quality of
Research.
|
Study
|
Age
|
Gender
|
Race/Ethnicity
|
|
Study 1
|
18-25 (Young adult)
26-55 (Adult)
55+ (Older adult)
|
79% Male
21% Female
|
45% Black or African American
32% White
15% Hispanic or Latino
8% Race/ethnicity unspecified
|
Quality of Research Ratings by Criteria (0.0-4.0 scale)
External reviewers independently evaluate the Quality of Research for an intervention's
reported results using six criteria:
For more information about these criteria and the meaning of the ratings, see Quality of Research.
|
Outcome
|
Reliability
of Measures
|
Validity
of Measures
|
Fidelity
|
Missing
Data/Attrition
|
Confounding
Variables
|
Data
Analysis
|
Overall
Rating
|
|
1: Substance use
|
3.5
|
3.0
|
3.5
|
4.0
|
3.5
|
4.0
|
3.6
|
|
2: HIV sexual risk behaviors
|
4.0
|
3.5
|
3.5
|
4.0
|
3.5
|
4.0
|
3.8
|
Study Strengths The substance use outcome measure is considered the gold standard for self-reports. Sample reliability was provided for the measure of HIV sexual risk behaviors, and prior research has documented the reliability of computer-delivered interviews for reporting behaviors of a sensitive nature. Treatment fidelity was strong in this study, which used a detailed manual, systematic training, and an adherence instrument. Missing data rates were low, and data that were missing were well managed with an intent-to-treat statistical approach and sophisticated data modeling. The study design included random assignment to conditions and a large sample size that provided statistical power to detect outcome differences between conditions. A sophisticated data analysis approach was used.
Study Weaknesses No biological measure such as urinalysis was used to strengthen the internal validity of self-reported drug use. Similarly, the validity of self-reported sexual behavior is an issue in this type of sensitive research; underreporting, both at pretest and follow-up, cannot be ruled out. As a result of minor problems with implementing random assignment, 9% of the study sample participated in the group to which they were not assigned.
|
|
