The review will identify and describe the existing evidence base of behaviour change interventions (BCIs) specifically designed to increase intended and/or actual condom use for HIV/STI prevention in older adults, synthesise their findings and evaluate their effectiveness.

What are the core components of BCIs which specifically seek to increase intended and/or actual condom use for HIV/STI prevention in older adults? -

Interventionist - What were the characteristics of those delivering the BCI?

Setting - Where was the BCI delivered?

Mode of Delivery - What were the methods of the BCI administration? (e.g. self-help, face-to-face, telephone, individual, group, community etc.)

Intensity - What was the length of time of each BCI contact and the total BCI contact time?

Frequency & Duration - How many sessions were there and how were they spaced? Over what time period was the BCI contact conducted?

Context - To what extent was the BCI theory-based and what was the theoretical framework?

Content - What behaviour change techniques (BCTs) - ‘active ingredients’ - were used in the BCI and how were they delivered? (e.g. oral communication, written material etc.)

Fidelity - What methodological strategies were in place to monitor and enhance the reliability and validity of the BCI?

What is the effectiveness of these targeted BCIs in increasing intended and/or actual condom use for HIV/STI prevention in older adults? -

Are BCIs more effective than waiting list or care as usual conditions?

Are BCIs more effective than minimal or other BCI conditions?

Are theory-based BCIs associated with better outcomes that those that are not based on theory?

What specific BCTs or clusters of BCTs and modes of delivery are associated with better outcomes?

Are BCIs with higher fidelity ratings associated with better outcomes?

Studies published in peer-reviewed journal articles will be searched for in -

PsycINFO

CINAHL

MEDLINE

EMBASE

Cochrane Central Register of Controlled Trials (CENTRAL)

Grey literature in the form of PhD theses will be searched for in -

Ethos British Library

OpenGrey

PQDT Open

Restrictions -

January 2000 to May 2012; Prior to 1980, research attention to sex, sexuality and health was almost non-existent but in the wake of the emerging HIV/AIDS epidemic in the early 1980s, the number of studies investigating sexual health behaviours flourished. However, it was not until the late 1980s/early 1990s that older adults began to be considered for inclusion (albeit on a small scale) in research of this nature. The majority of sexual health research concerning older adults in the 1990’s was in relation to establishing whether or not they were sexually active, initial investigations of whether sexual activity was risky, and HIV/STI epidemiology. The development, implementation and assessment of BCIs designed specifically to increase intended and/or actual condom use for HIV/STI prevention in older adults has emerged as a response to the results of this earlier research; this is how the cut-off date for inclusion in the review was reached.

Engligh language.

Humans; male and female.

A citation search of the reference lists from studies identified as relevant to the review will also be conducted to identify further potentially relevant studies.

The review will consider studies with the following research designs:

Randomised controlled trials (RCTs)

Controlled trials (CTs)

Studies without comparator and/or control conditions will be excluded on the basis that it is impossible to know what would have happened without the BCI.

Intended and/or actual condom use.

The review will consider studies that include men and/or women over 40 years of age regardless of gender identity, sexual orientation, STI history, current HIV/STI status, ethnicity, nationality, social economic status, marital status, or educational status. Studies that focus exclusively on commercial sex workers, victims of sexual abuse/violence or domestic violence, intravenous drug users, those in prison, psychiatric facilities or nursing homes, or those with no fixed address e.g. homeless or sleeping rough, will be excluded as these groups have distinct needs in terms of BCIs that are beyond the scope of the review. Studies that include a subgroup of men and/or women over 40 years but do not tailor the BCI to meet the unique needs of older adults will also be excluded.

The review will consider studies that implemented and assessed primary or secondary BCIs designed specifically to increase intended and/or actual condom use for HIV/STI prevention in older adults. BCIs could focus on any number of BCTs e.g. modelling, cognitive restructuring, skills training, goal setting, information provision in relation to condom use as an effective STI risk reduction strategy etc.

Studies must include control (i.e. waiting list or care as usual) and/or comparator BCI conditions (i.e. minimal or other BCI). Stand-alone BCIs will be excluded.

Primary outcomes

The review will consider studies with the following primary outcome measure -

Behavioural - Intended and/or actual condom use for HIV/STI prevention. Data must be available for at least one of the following: reported intention to engage in unprotected/protected anal, vaginal, or oral sex or reported unprotected/protected anal, vaginal, or oral sex (actual condom use) measured at baseline (prior to the BCI) and with at least one follow-up measurement.

The primary outcome will be categorised into short, medium or long-term, defined as the following -

Short-term - <6 months post-BCI

Medium-term - 6 to 12 months post-BCI

Long-term - >12 months post-BCI

Secondary outcomes

For studies that meet the primary outcome measure inclusion criteria, information on the following secondary outcomes will be reported (i.e. described in narrative form but not formally assessed in meta-analysis) where possible -

Biological - HIV/STI incidence or prevalence.

Learning - e.g. Knowledge of HIV/STIs (including knowledge of condom use as an effective HIV/STI risk reduction strategy); condom negotiation/communication skills; condom application skills.

Cognition - e.g. condom use self-efficacy; condom related attitudes and beliefs; risk perception.

Cost Effectiveness - Economic evaluation of a BCI.

Secondary outcomes will be categorised into short, medium or long-term, defined as the following -

Short-term - <6 months post-BCI

Medium-term - 6 to 12 months post-BCI

Long-term - >12 months post-BCI

Two independent reviewers (JM & GD) will extract key details from studies included in the review using a structured review-specific data extraction tool developed by the principal investigator (JM). Data extracted will include information relating to -

Bibliographic details

Study design

Aim, rationale & ethics

PICO

Analysis

Results

Conclusions

Implications

Limitations

A 19-item Theory Coding Scheme (TCS) developed by Michie & Prestwich (2010) will be applied (JM & PF) to studies included in the review in order to establish the extent to which BCIs were theory-based.

Descriptions of BCI content will be coded (JM & PF) into BCTs using a 93-item revised version (Michie, Abraham, Eccles, Francis, Hardeman & Johnston (2011); Michie, Richardson, Johnston, Abraham, Francis, Hardeman & Eccles (in preparation)) of the Taxonomy of generally applicable BCTs proposed by Abraham & Michie (2008).

A 30-item revised version (Borrelli, 2011) of the comprehensive Fidelity Checklist developed by Borrelli et al. (2005) will be used to code (JM & PF) for the presence or absence of a number of important characteristics related to fidelity.

Any disagreements in the data extraction and coding process will be resolved by consensus through discussion or by seeking the opinion of another reviewer (KL). Corresponding authors of studies included in the review will be contacted to clarify any missing or unclear information.

References:

Abraham, C. & Michie, S. (2008). A Taxonomy of Behavior Change Techniques Used in Interventions, Health Psychology, 27 (3), 379-387.

Borrelli, B. (2011). The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials, Journal of Public Health Dentistry, 71, S52-S63.

Borrelli, B., Sepinwall, D., Ernst, D., Bellg, A.J., Czajkowski, S., Breger, R., DeFrancesco, C., Levesque, C., Sharp, D.L., Ogedegbe, G., Resnick, B., & Orwig, D. (2005). A New Tool to Assess Treatment Fidelity and Evaluation of Treatment Fidelity Across 10 Years of Health Behavior Research, Journal of Consulting and Clinical Psychology, 73 (5), 852-860.

Michie, S., Abraham, C., Eccles, M., Francis, J., Hardeman, W., Johnston, M. (2011). Strengthening evaluation and implementation by specifying components of behaviour change interventions: a study protocol, Implementation Science, 6, 10. DOI: 10.1186/1748-5908-6-10.

Michie, S. & Prestwich, A. (2010). Are Interventions Theory-Based? Development of a Coding Scheme, Health Psychology, 29 (1), 1-8.

Michie, S., Richardson, M., Johnston, M., Abraham, C., Francis, J., Hardeman, W., Eccles, M. (in preparation). The Behaviour Change Technique Taxonomy (v1) of 93 hierarchically-clustered techniques: building an international consensus for the reporting of behavior change interventions (working title). BCT Taxonomy v1 FINAL, August 15th 2012.

An assessment of risk of bias will be conducted for each study included in the review by two independent reviewers (JM & GD). The principal investigator (JM) will create a structured review-specific risk of bias assessment tool by amalgamating content from the evaluative framework for RCTs developed by the Cochrane Collaboration (Higgins, Altman & Sterne in Higgins & Green, 2011) with supplementary content from the handbook developed by the Scottish Intercollegiate Guidelines Network (SIGN; 2011) and instruments previously reviewed by Deeks, Dinnes, D’Amico, Sowden, Sakarovitch, Song, Petticrew & Altman, (2003); the Quality Assessment Tool for Quantitative Studies (Effective Public Health Practice Project (EPHPP), 1998) and Downs and Black (1998). The domains recommended by the Cochrane Collaboration (Higgins et al. in Higgins & Green, 2011) will all be covered:

Selection bias

Performance bias

Detection bias

Attrition bias

Reporting bias

These domains are similarly considered useful for assessing risk of bias in CTs in which allocation to groups is not randomised; however, an additional component should also be included in such instances (Reeves, Deeks, Higgins & Wells in Higgins & Green, 2011):

Confounding and adjustment bias

Thus, each study included in the review will be subject to an assessment of risk of bias across 6 domains. Summary assessments of studies will result in an overall risk of bias rating as described by SIGN (2011):

Very low risk- all or most of the criteria have been met and where they have not been fulfilled the conclusions of the study are thought very unlikely to alter

Low risk - some of the criteria have been met and those that have not been fulfilled or are inadequately described are thought unlikely to alter the conclusions

High risk - few or no criteria have been met and the conclusions of the study are thought likely or very likely to alter

Studies will not be excluded from the review based on their overall risk of bias rating; however, similar to the SIGN (2011) approach, coupled with study design, it will determine the level of evidence that the study provides. For example, on a ‘levels of evidence’ scale ranging from 1++ to 4 (expert opinion), RCTs will automatically be graded at the highest level of evidence (1++). Studies with an RCT design will stay at this level if their overall risk of bias is very low but will be down-weighted to lower levels of evidence (1+ or 1-) if they are summarised as low or high risk of bias, respectively. Conversely, CTs will automatically be graded at 2++ on the ‘levels of evidence’ scale. Studies with a CT design will stay at this level if their overall risk of bias is very low but will be down-weighted to lower levels of evidence (2+ or 2-) if they are summarised as low or high risk of bias, respectively.

Any disagreements in the assessment of risk of bias process will be resolved by consensus through discussion or by seeking the opinion of a third reviewer (KL). Corresponding authors of studies included in the review will be contacted to clarify any missing or unclear information.

References -

Deeks, J.J., Dinnes, J., D’Amico, R., Sowden, A.J., Sakarovitch, C., Song, F., Petticrew, M. & Altman, D.G. (2003). Evaluating non-randomised intervention studies, Health Technology Assessment, 7 (27).

Downs, S.H. & Black, N. (1998). The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions, Journal of Epidemiology & Community Health, 52, 377-384.

Effective Public Health Practice Project. (EPHPP; 1998). Quality Assessment Tool for Quantitative Studies, [Online], Available http://www.ephpp.ca/PDF/Quality%20Assessment%20Tool_2010_2.pdf. [23rd May 2012].

Higgins, J.P.T., Altman, D.G. & Sterne, J.A.C. (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins, J.P.T. & Green, S. (editors). Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0 (updated March 2011) [Online]. The Cochrane Collaboration, 2011. Available http://www.cochrane-handbook.org. [23rd May 2012].

Higgins, J.P.T. & Green, S. (editors). Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0 (updated March 2011) [Online]. The Cochrane Collaboration, 2011. Available http://www.cochrane-handbook.org. [28th April 2012].

Reeves, B.C., Deeks, J.J., Higgins, J.P.T. & Wells, G.A. Chapter 13: Including non-randomized studies. In: Higgins, J.P.T. & Green, S. (editors) Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0 (updated March 2011) [Online]. The Cochrane Collaboration, 2011. Available http://www.cochrane-handbook.org. [28th April 2012].

Scottish Intercollegiate Guidelines Network. (SIGN; 2011). SIGN 50 A guideline developer’s handbook, [Online], Available http://www.sign.ac.uk/pdf/sign50.pdf. [23rd May 2012].

Where possible, the results of the primary outcome measure of similar studies will be pooled and a meta-analysis performed. However, there is likely to be substantial dissimilarities across studies included in the review with regards to factors such as the content and duration of BCIs, the interventionists, the population under study e.g. sexual orientation, differences in age, (those over 40 years compared to those over 60 years), the measurement of intended/actual condom use and risk of bias rating. Thus, pooling of data will only occur after completion of appropriate testing. In the event of a significant degree of heterogeneity or the majority of studies having an overall high or low risk of bias, results of the primary outcome of studies will be synthesised in narrative form along with those of the secondary outcomes. In the absence of a significant degree of heterogeneity and there being some studies with high or low risk of bias (but they do not represent the majority), these studies will be excluded from the meta-analysis; that is, it will be restricted to studies at very low risk of bias only (Higgins et al. in Higgins & Green, 2011).

References -

Higgins, J.P.T., Altman, D.G. & Sterne, J.A.C. (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins, J.P.T. & Green, S. (editors). Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0 (updated March 2011) [Online]. The Cochrane Collaboration, 2011. Available http://www.cochrane-handbook.org. [23rd May 2012].

Higgins, J.P.T. & Green, S. (editors). Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0 (updated March 2011) [Online]. The Cochrane Collaboration, 2011. Available http://www.cochrane-handbook.org. [28th April 2012].

None planned.

Reporting of the review will be based as closely as possible on the PRISMA statement (Liberati, Altman, Tetzlaff, Mulrow, Gotzsche, Ioannidis, Clarke, Devereux, Kleijnen, & Moher, 2009; Moher, Liberati, Tetzlaff, & Altman, 2009), which details the preferred reporting items for systematic reviews and meta-analyses. At least one manuscript for publication will be submitted to a reputable peer-reviewed journal in this field (ageing/sexual behaviour/health psychology); results will also be submitted to relevant local, national, and international conferences.

References

Liberati, A., Altman, D.G., Tetzlaff, J., Mulrow, C., Gotzsche, P., Ioannidis, J.P.A., Clarke, M., Devereux, P.J., Kleijnen, J., & Moher, D. (2009). The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration, British Medical Journal, 339, b2700.

Moher, D., Liberati, A., Tetzlaff, J., & Altman, D.G.; PRISMA Group (2009). Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement, British Medical Journal, 339, b2535.

Jennifer MacDonald

K418 Buchanan House

Institue for Applied Health Research/School of Health and Life Sciences

Glasgow Caledonian University

Cowcaddens Road

Glasgow

G4 0BR

jennifer.macdonald@gcu.ac.uk

Glasgow Caledonian University

www.gcu.ac.uk

Miss Jennifer MacDonald, Glasgow Caledonian University
Dr Karen Lorimer, Glasgow Caledonian University
Dr Christina Knussen, Glasgow Caledonian University
Mr Graeme Donald, Glasgow Caledonian University
Professor Paul Flowers, Glasgow Caledonian University

27 March 2012

31 October 2012

PhD Studentship from Glasgow Caledonian University

None known

English

Scotland

Subject indexing assigned by CRD

Condoms; Sexually Transmitted Diseases; Health Behavior; Health Promotion; Humans

12 July 2012

08 January 2013