Implementation Science of Pre-exposure Prophylaxis: Preparing for Public Use

As efficacy trials of antiretroviral pre-exposure prophylaxis (PrEP) continue, a growing literature has begun anticipating the potential challenges of implementing PrEP for HIV prevention. These efforts coincide with a shift toward combination interventions for preventing HIV, which integrate biomedical, behavioral, and structural components. The optimal implementation of PrEP would exemplify this combination model, incorporating not only PrEP drugs, but also HIV testing, safety screening, behavioral interventions addressing adherence and risk behavior, and long-term monitoring. Efforts to plan for PrEP implementation therefore present an opportunity to advance the science of implementation and delivery in HIV prevention, in order to better address the challenges of scaling up combination approaches. We review the published and unpublished literature on PrEP implementation, organizing themes into five categories: scientific groundwork, regulatory and policy groundwork, stakeholder and infrastructure groundwork, delivery, and long-term monitoring. The lessons from PrEP planning can benefit the scale-up of future combination interventions.     

Development of a comprehensive health-related needs assessment for adult survivors of childhood cancer

Purpose

Examine the construct validity, stability, internal consistency, and item–response performance of a self-report health needs assessment for adult survivors of childhood cancer.

Methods

A 190-item mailed survey was completed by 1,178 randomly selected (stratified on age, diagnosis, time since diagnosis) Childhood Cancer Survivor Study participants (mean age, 39.66 [SD 7.71]?years; time since diagnosis, 31.60 [SD 4.71]?years). Minorities and rural residents were oversampled at a 2:1 ratio.

Results

The final instrument included 135 items comprising nine unidimensional subscales (Psycho-emotional, Health System Concerns, Cancer-Related Health Information, General Health, Survivor Care and Support, Surveillance, Coping, Fiscal Concerns, and Relationships). Confirmatory factor analysis (n?=?1,178; RMSEA?=?0.020; 90 % CI?=?0.019–0.020; CFI?=?0.956; TLI?=?0.955) and person–item fit variable maps established construct validity. Across subscales, Cronbach’s alpha was 0.94–0.97, and the 4-week test–retest correlations were 0.52–0.91. In a Rasch analysis, item reliability was 0.97–0.99, person reliability was 0.80–0.90, and separation index scores were 2.00–3.01. Significant subscale covariates of higher need levels included demographics, diagnosis, and treatment exposures.

Conclusions

The Childhood Cancer Survivor Study Needs Assessment Questionnaire (CCSS-NAQ) is reliable and construct-valid, has strong item–response properties, and discriminates need levels.

Implications for Cancer Survivors

The CCSS-NAQ potentially can be used to: (1) directly assess adult childhood cancer survivors’ self-reported health-related needs, (2) identify individuals or subgroups with higher-level needs, (3) inform prevention and direct intervention strategies, and (4) facilitate prioritization of health-care resource allocation.     

Botulinum toxin type A for the treatment of urinary tract dysfunction in neurological disorders

Botulinum toxin type A injections represent an important therapeutic option for patients with neurogenic urinary dysfunction in whom conservative treatment has not been effective. The nurse's role in ensuring that these patients receive appropriate assessment and treatment is discussed.     

Hemorrhagic colitis due to a novel Escherichia coli serotype (O121:H19) in a transplant patient

Infection due to enterohemorrhagic Escherichia coli (EHEC) has not been described in immunosuppressed patients. We recently saw a case of EHEC infection caused by a novel Shiga toxin II-producing Escherichia coli serotype (O121:H19) that caused hemorrhagic colitis in a patient with renal and cardiac transplants. The patient's signs, symptoms, and colon pathology were similar to reports of EHEC infection in immunocompetent patients. This case suggests that the immunosuppressed state may not alter the clinical presentation or histopathologic findings of this disorder. Assays for EHEC are not routinely done at most hospitals. Therefore, clinicians caring for transplant patients should be aware of the typical clinical presentation of EHEC infection, so that they can initiate appropriate laboratory investigation in suspected cases. Received: 27 December 1999 Accepted: 13 September 2000