EARLY DETECTION OF HIV infection may facilitate both prevention 1 and early treatment. 2-5 In addition, detection of HIV within the first few months of infection is crucial for assessments of early treatment interventions, early pathogenesis, and evaluation of the effects of HIV vaccines on very early HIV infection. Early detection is particularly relevant for persons at high risk of acquiring infection, such as men who have sex with men, injection drug users, and persons with multiple sex partners.
Current methods for earlier detection of HIV infection include increasing the frequency of standard HIV counseling and testing, which would be both costly and burdensome for clients and counselors. More frequent testing using home specimen collection and telephone counseling may promote earlier detection of HIV infection. 6-9 However, few data exist documenting the acceptability, feasibility, safety, and effectiveness of home specimen collection among high-risk populations for which it may be particularly relevant.
The US Food and Drug Administration approved the first HIV home-sample collection kit in 1996, after l0 years of consideration. 10,11 This kit requires home collection of a finger-stick specimen on a filter paper, which is dried and mailed to a laboratory for antibody testing. Results are received through accessing a telephone recording with an anonymous code, or if positive by speaking with a counselor and receiving referrals over the telephone. Despite the lengthy approval process, there have been few data reported in the literature specifying the attitudes of high-risk persons toward home specimen collection and telephone counseling. One national study conducted in 1992 found that 29% of respondents would choose home HIV tests over alternatives, among whom 42% of those defined as at risk for HIV infection said they would do so. Those who were more likely to express an interest in home HIV specimen collection had fewer years of education, lower incomes, and were more likely to be black or Hispanic-the same population groups that have been disproportionately affected by HIV in the United States. 12
Initial studies assessing the use of home specimen collection kits 13,14 and telephone counseling 9 have been encouraging. In Branson's postmarketing population-based evaluation of home dried blood spot collection and telephone counseling, 95% of 174,316 persons were able to collect specimens adequate for testing, and 97% of users called to get their test results. In addition, 88% of 1,569 clients with HIV reportedly accepted referrals or had follow-up care. Survey data from a self-selected portion of the clients revealed that 50% had never been tested, and clients who test positive for HIV were more likely to be men who have sex with men, injection drug users, and nonwhite. Although there are no published data concerning home oral-fluid collection, Major et al 8 found that among injection drug users, 89% were willing to provide saliva for HIV testing, whereas only 69% were willing to provide blood through venipuncture. Thus oral fluid collection may be more acceptable than blood collection among high-risk persons.
We present findings from a multisite evaluation of the acceptability of monthly home oral fluid and dried blood spot collection and telephone counseling. To better understand concerns about home specimen collection and telephone counseling, we conducted focus groups and administered surveys to 47 staff involved in HIV counseling and testing, 68 participants from the HIV Network for Prevention Trials Vaccine Preparedness Study (VPS), and 11 Community Advisory Board (CAB) members acting as advocates for cohort participants. The findings provide insight to the potential use of home specimen collection and telephone counseling for early detection of HIV infection among participants in high-risk cohorts in which clients are followed up over time for the purpose of assessing interventions to prevent HIV infection.
Methods
The VPS, a multisite prospective study of 4,892 persons at high risk for HIV infection, began in 1995 to evaluate the feasibility of HIV prevention and vaccine-efficacy trials. VPS participants were enrolled in the cohort because of ongoing behaviors that place them at risk for acquiring HIV (i.e., men who have sex with men, injection drug users, and women at heterosexual risk). Participants were asked to come to the site every 6 months for 18 months for HIV testing and to complete in-depth interviews about risk behaviors and attitudes regarding vaccine trials and other HIV-prevention interventions.
The HIV Early Detection study was conducted within the VPS cohort in the spring of 1997. All counseling staff, CAB members, and a convenience sample of participants from the VPS study sites in six of the eight participating cities (Denver, New York, Philadelphia, Providence, San Francisco, and Seattle) were invited to participate in focus group discussions and surveys about new methods for HIV counseling and testing. Although most study participants were selected through convenience sampling of VPS participants attending the site for routine visits, attention was paid to achieving representation in terms of age, sex, and race or ethnicity that were proportionate to all VPS subjects. All VPS participants received $20 and a meal as compensation for their time.
Two focus groups were conducted at each study site: one consisting only of VPS participants, and the other of staff and CAB members. These groups were held separately to allow participants to express their views openly, and took place in private conference rooms associated with the clinics. Notes and audiotapes were recorded during the focus groups. Surveys were piloted among participants at the first two sites and then revised based on the initial focus group discussions. After self-administered surveys were completed, a discussion occurred that focused on a proposed study protocol in which participants would complete monthly home specimen collection and receive HIV counseling and preliminary test results by telephone for a 6-month period.
During each focus group session, specimen collection kits using oral fluid (Epitope, Beaverton, OR) and dried blood spot (ChemTrak, Sunnyvale, CA) were discussed and demonstrated. Specimen testing procedures and telephone counseling methods also were described, including the plan that positive results for specimens collected at home would indicate the need for additional on-site counseling and testing. The discussion focused on a proposed study protocol in which participants would complete monthly home specimen collection and receive HIV counseling and preliminary test results by telephone for a 6-month period. After the demonstration, focus group participants were encouraged to try each specimen collection method and to complete a questionnaire regarding the acceptability of the proposed study. Finally, a semistructured discussion was conducted using open-ended questions to further explore participant attitudes and concerns. Results from the self-administered questionnaire were entered into the SPSS software program (SPSS Inc., Chicago, IL) and were tabulated. Differences between staff and CAB and participant responses were statistically compared using the chi-square test. Text from open-ended survey responses was first entered into Ethnograph, a software program for qualitative data analysis (Qualis Research Associates, Salt Lake City, UT), and coded for themes by two readers. This coding was entered into SPSS and tabulated. The audio-tapes of focus groups were reviewed, but no additional themes were discovered.
Staff and CAB focus groups consisted of 47 staff members and 11 CAB members, respectively (total, 58 participants; 8-13 participants at each site). The VPS participant focus groups included 68 VPS participants (8-14 participants at each site), and 62 of the focus group participants completed surveys. CAB members who were community advocates had responses similar to those of staff; therefore, their results have been combined with staff results. Similarly, CAB members who were also participants responded more like other participants, and their responses were combined with participant results.
Results
Enrollment
Participation rates were approximately 80%, and most persons who refused cited schedule conflicts. The study sample had significantly more women, and a different race and ethnicity distribution, with more blacks and fewer Hispanics compared with the full VPS cohort. However, the sample was similar regarding age and risk group(Table 1).
Willingness to Try Collection Methods
Nearly all VPS participants were willing to try both oral fluid collection (99%) and dried blood spot collection (93%) during the focus groups. The five participants who did not try dried blood spot collection were from diverse risk groups and study sites. All staff and CAB members tried oral fluid collection, but only 80% tried dried blood spot collection. The participants, staff, and CAB who did not try dried blood spot specimen collection refused because they were afraid of discomfort from the finger-stick device.
Among those who tried dried blood spot collection, two participants and one staff member found it too uncomfortable. No participants and two staff member found it too difficult. Among those who tried oral fluid collection, no participants and one staff member found it too uncomfortable because of the aftertaste, and no participant or staff member found the method too difficult.
Willingness to Collect Monthly Specimens
Ninety-two percent of VPS participants reported a willingness to participate in a study that required monthly collection of both oral fluid and dried blood spots. Two of the three unwilling participants said finding out my HIV test results every month would make me anxious, and the third was comfortable with oral fluid tests but was afraid that collecting dried blood spots would hurt too much.
Impact of Frequent HIV Testing
The concerns of VPS staff and CAB members about the potential deleterious impact of frequent HIV testing usually did not correspond with those of VPS participants (Table 2). Significantly, only 10% of the VPS participants believed that monthly HIV testing would make them more anxious, whereas 44% of staff and CAB members believed that it would. Similarly, although no participants felt that frequent negative HIV test results would cause persons to feel immune to HIV and therefore take more HIV exposure risks, this concern was brought up at all sites by staff and CAB members. However, in the surveys only 6% of staff and CAB members stated that they believed monthly testing would cause VPS participants to take more HIV risks.
Acceptability, Effectiveness, and Safety of Telephone Counseling
Other concerns centered on the acceptability, effectiveness, and safety of telephone counseling. Nearly three quarters (73%) of VPS participants reported a preference for telephone versus on-site counseling when undergoing monthly testing (Table 3), whereas less than half (43%) of staff and CAB members believed that participants would prefer telephone counseling, and only 7% of staff and CAB members preferred counseling by telephone. A representative comment from one staff member illustrates a common concern: For some participants I would worry that they would 'freak out' when they got their results. This has happened already-both for negative and positive results. As a counselor I don't have as much 'control' over things if it's all via phone. Forty percent of the staff and CAB group preferred on-site counseling, and 47% thought VPS participants should be offered their choice (data not shown).
Eighty-eight percent of VPS participants believed counseling to be helpful in reducing their HIV risk behavior, and 74% said that they thought that in-person counseling on site would be more effective than telephone counseling. Regardless, 67% of participants wanted to receive their monthly test results without in-person risk-reduction counseling. As one participant said, I agree that I would not want to hear bad news over the phone, but I also would not like coming into the clinic every month-a conflict that I don't know if it has a good solution. Compared with participants, a similar percentage of staff and CAB members (85%) believed that in-person counseling would be more effective than telephone counseling, and 59% of staff and CAB members wanted VPS participants to receive risk-reduction counseling every month. A common belief appeared to be that frequent risk-reduction counseling could help participants reduce high-risk behavior or keep it from escalating [by] teach[ing] negotiation skills. Staff and CAB were more concerned about what would be effective in helping clients reduce their HIV risks, and less concerned about the burden on participants that would result from monthly face-to-face counseling.
Most staff and CAB members also had concerns about the potential risks of providing positive HIV test results over the telephone, including concerns that participants may fail to follow up with face-to-face counseling or partner notification, have suicidal ideation, or increase their HIV risk-taking. Questionnaire responses indicated that VPS participants did not share such concerns. For example, 95% of VPS participants reported that they would attend an appointment for in-person counseling and a confirmatory blood draw (Table 4). In contrast, only 58% of staff and CAB members thought that VPS participants would complete confirmatory appointments. Among staff and CAB members, 59% were concerned that VPS participants might become suicidal, and 41% were concerned that VPS participants might take more HIV risks. No VPS participants said they were worried that they might become suicidal, and only 1 of 62 believed that they might take more HIV risks after receiving positive results by telephone.
Other Concerns About Home Specimen Collection and Telephone Counseling
The perceived advantages of home specimen collection and telephone counseling were similar for VPS participants, staff, and CAB members (Table 5). All groups noted convenience, ease of use, and time efficiency. They also liked the decreased travel time, increased privacy, and flexibility associated with home testing. Participants mentioned that they would be more comfortable collecting specimens and getting test results in their own home. They also thought that home specimen collection would be less painful than phlebotomy. Staff and CAB members mentioned that home specimen collection might empower VPS participants to become more involved in their own health care. The same average number of positive comments per person was cited by VPS participants (3.3), and staff and CAB participants (3.3).
The staff and CAB group mentioned many more potential disadvantages than VPS participants (Table 5). Most of these concerns stemmed from their distrust of telephone counseling (i.e., inappropriateness for high-risk persons, potential ineffectiveness for risk reduction, counselor's lack of control or ability to gauge participant response, fear that participants given positive results by phone may be made anxious and be more likely to come to harm, commit suicide, take more HIV risks, or engage in partner abuse). In the focus groups, the few staff who had previous experience working on crisis telephone lines were more comfortable with the concept of telephone counseling. Other disadvantages brought up by staff and CAB involved participant responses and behavior (e.g., the potential for increased anxiety with frequent testing, noncompliance with home specimen collection). They were also concerned about the potential for technical problems, believing that specimen collection may be too difficult for participants and that the identity of the specimens may not be reliable.
In contrast, participants brought up few concerns about home specimen collection and telephone counseling. They agreed with staff and CAB members that telephone counseling was impersonal and might be inadequate for discussing HIV-positive test results. Further concerns were voiced that home specimen collection may be error prone. The only other theme, which was mentioned by more than three VPS participants, was dislike of the required 4-hour drying time for the dried blood spot specimen. When considering those disadvantages mentioned at each site, the VPS participant group averaged 2.5 disadvantages per person whereas the staff and CAB group averaged 3.7 disadvantages per person (P = 0.003). No difference in the qualitative responses was noted between sites.
Despite the concerns mentioned, the majority of VPS participants (98%) and staff and CAB members (79%) said that a study should be done to evaluate monthly home specimen collection and telephone counseling among persons at high risk.
Discussion
This study suggests that participants in a high-risk cohort would find home specimen collection and telephone counseling acceptable and even preferable when testing for HIV on a frequent (e.g., monthly) basis. The most striking finding was that the numerous concerns raised by staff and CAB members were not widely shared by VPS participants. Although VPS participants identified some potential disadvantages of home specimen collection and telephone counseling, the number of advantages identified were significantly greater. Furthermore, most of the concerns raised by staff and CAB members regarding the risks of telephone counseling were not shared by VPS participants.
Although these results suggest that home specimen collection and telephone counseling may be useful tools in a research setting for repeat testing and early detection of HIV infection among persons at high risk, the study population was not a random sample. Participants in this study may represent the most compliant in the cohort-those who show up to their appointments and tell the investigators what they think they want to hear. Therefore, these data may not accurately reflect the perceptions of the larger cohort. The impact of this selection bias may have been limited by the inclusion of participants with representative demographic characteristics and because of high participation rates among those approached. However, these findings may not be generalizable to other research groups or to broader populations of persons at high risk. The acceptability of home specimen collection and telephone counseling among participants in this study may also be overestimated given the demonstration of kits during the focus groups, which likely increased comfort with the collection methods. However, this bias is minimized because the survey data were collected before the kit demonstrations. In addition, these data only describe hypothetical behavior, which may not accurately predict actual behavior.
The concerns voiced by staff and CAB members in this study regarding the effectiveness and safety of telephone counseling may be the most significant barrier to the implementation of home specimen collection and telephone counseling in both research studies and in the public sector. Although there are no studies that have adequately assessed the validity of these concerns, a recent study reported that in a postmarketing evaluation of the Home Access home HIV specimen collection kit, no adverse events were reported among 1569 clients with HIV-positive test results. 13 However, in that study adverse events would only have been collected among clients who called back to report their results.
The main motivation of staff and CAB appeared to be to protect the well-being of the participants and to avoid being in the uncomfortable position of giving positive test results over the telephone. Many of their concerns about home specimen collection and telephone counseling likely come from this desire. Most counselors who have given HIV-positive test results face-to-face in the past have had some clients who have had strong emotional reactions or became withdrawn and uncommunicative. Consequently, they feel even more challenged by the idea of managing these clients on the telephone, especially without previous experience managing crises by telephone. As mentioned, the few who had previous experience working on crisis telephone lines were more comfortable with the concept of telephone counseling. An alternative explanation for staff concerns could be the potential impact on their job security, yet this was not a finding voiced in this study. Until more data are available on the safety and effectiveness of home specimen collection and telephone counseling, decisions to use these methods will need to balance the concerns voiced by staff with the potential benefits, such as greater use of testing among high-risk populations and reduced client burden.
The first considerations of home specimen collection and telephone counseling as a method for early detection of HIV infection in this cohort evoked significant concerns among staff and CAB members. However, the process of conducting the focus groups described here reduced barriers to implementing these new methods by allowing staff and CAB members to voice their concerns and, through review of this data, to hear the alternative views of participants. After hearing the participants' perspectives, even the most adamantly opposed staff thought that it was worthwhile to move forward with a larger study to measure the actual feasibility of bimonthly home specimen collection and telephone counseling among a larger sample of VPS participants. As predicted by participants' responses, the subsequent randomized evaluation showed both high acceptability and feasibility of home collection of oral fluid and dried blood spot specimens for more frequent HIV testing. 15 We have demonstrated that counselors and patient advocates may discourage innovative approaches for HIV testing that consumers may be interested in pursuing, and that in the case of home HIV specimen collection and telephone counseling, their opinions were a poor gauge of user attitudes. Similar studies may have an important role in helping the diffusion of new controversial technologies in the public sector and in research settings.
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