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Methodological overview of an African American couple-based HIV/STD prevention trial.
J Acquir Immune Defic Syndr 2008; 49 Suppl 1:S3-14JA

Abstract

OBJECTIVE

To provide an overview of the National Institute of Mental Health Multisite HIV/sexually transmitted disease (STD) Prevention Trial for African American Couples conducted in 4 urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described.

DESIGN

This is a 2-arm randomized trial, implementing a modified randomized block design, to evaluate the efficacy of a couples-based intervention designed for HIV-serodiscordant African American couples.

METHODS

The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV-serodiscordant heterosexual African American couples. There are 2 theoretically derived behavioral interventions with 8 group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction whereas the control was individual based and focused on health promotion. The 2 study conditions were structurally similar in length and types of activities. At baseline, participants completed an audio computer-assisted self-interview and interviewer-administered questionnaire and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months.

RESULTS

The trial results will be analyzed across the 4 sites by randomization assignment. Generalized estimating equations and mixed-effects modeling are planned to test: (1) the effects of the intervention on STD incidence and condom use and on mediator variables of these outcomes and (2) whether the effects of the intervention differ depending on key moderator variables (eg, gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history).

CONCLUSIONS

The lessons learned from the design and conduct of this clinical trial provide guidelines for future couples-based clinical trials in HIV/STD risk reduction and can be generalized to other couples-based behavioral interventions.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

18724188

Citation

NIMH Multisite HIV/STD Prevention Trial for African American Couples Group. "Methodological Overview of an African American Couple-based HIV/STD Prevention Trial." Journal of Acquired Immune Deficiency Syndromes (1999), vol. 49 Suppl 1, 2008, pp. S3-14.
NIMH Multisite HIV/STD Prevention Trial for African American Couples Group. Methodological overview of an African American couple-based HIV/STD prevention trial. J Acquir Immune Defic Syndr. 2008;49 Suppl 1:S3-14.
NIMH Multisite HIV/STD Prevention Trial for African American Couples Group. (2008). Methodological overview of an African American couple-based HIV/STD prevention trial. Journal of Acquired Immune Deficiency Syndromes (1999), 49 Suppl 1, pp. S3-14. doi:10.1097/QAI.0b013e3181842570.
NIMH Multisite HIV/STD Prevention Trial for African American Couples Group. Methodological Overview of an African American Couple-based HIV/STD Prevention Trial. J Acquir Immune Defic Syndr. 2008 Sep 1;49 Suppl 1:S3-14. PubMed PMID: 18724188.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Methodological overview of an African American couple-based HIV/STD prevention trial. A1 - ,, PY - 2008/9/25/pubmed PY - 2008/10/10/medline PY - 2008/9/25/entrez SP - S3 EP - 14 JF - Journal of acquired immune deficiency syndromes (1999) JO - J. Acquir. Immune Defic. Syndr. VL - 49 Suppl 1 N2 - OBJECTIVE: To provide an overview of the National Institute of Mental Health Multisite HIV/sexually transmitted disease (STD) Prevention Trial for African American Couples conducted in 4 urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described. DESIGN: This is a 2-arm randomized trial, implementing a modified randomized block design, to evaluate the efficacy of a couples-based intervention designed for HIV-serodiscordant African American couples. METHODS: The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV-serodiscordant heterosexual African American couples. There are 2 theoretically derived behavioral interventions with 8 group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction whereas the control was individual based and focused on health promotion. The 2 study conditions were structurally similar in length and types of activities. At baseline, participants completed an audio computer-assisted self-interview and interviewer-administered questionnaire and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months. RESULTS: The trial results will be analyzed across the 4 sites by randomization assignment. Generalized estimating equations and mixed-effects modeling are planned to test: (1) the effects of the intervention on STD incidence and condom use and on mediator variables of these outcomes and (2) whether the effects of the intervention differ depending on key moderator variables (eg, gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history). CONCLUSIONS: The lessons learned from the design and conduct of this clinical trial provide guidelines for future couples-based clinical trials in HIV/STD risk reduction and can be generalized to other couples-based behavioral interventions. SN - 1525-4135 UR - https://www.unboundmedicine.com/medline/citation/18724188/Methodological_overview_of_an_African_American_couple_based_HIV/STD_prevention_trial_ L2 - http://Insights.ovid.com/pubmed?pmid=18724188 DB - PRIME DP - Unbound Medicine ER -