Jones, HE, Altini L, de Kock A, Young T, van de Wijgert JHHM. Home-based versus clinic-based self-sampling and testing for sexually transmitted infections in Gugulethu, South Africa: randomised controlled trial. Sex Transm Infect 2007 Dec;83(7):552-7.
To test whether more women are screened for sexually transmitted infections (STIs) when offered home-based versus clinic-based testing and to evaluate the feasibility and acceptability of self-sampling and self-testing in home and clinic settings in a resource-poor community.
Randomized clinical trial.
The Empilisweni Wellness Center, a clinical trial research site in Gugulethu, South Africa.
Eligible women were 14-25 years old, had at least a grade 5 education to ensure literacy, and did not report genital ulcers or other symptoms in need of immediate gynecological care. Of 733 women recruited, 626 (85%) were eligible and chose to participate, with 313 randomized to each group. Most participants were recruited from the nearby Uluntu clinic (49%), followed by the Nyanga clinic (36%), and non-clinic youth groups (14%). The median age was 20.0 years (interquartile range [IQR] =17 to 22) and the median years of education was 11.0 (IQR=10 to 12). Ninety-one percent had ever had sex, the median number of sexual partners was 2.0 (IQR=1 to 3), 19.5% had ever been treated for an STI, and 55.3% were very worried about STIs. No differences were found between the home and clinic groups in baseline sociodemographic characteristics and sexual history. Ninety-one percent (569) completed their 6-week follow-up visit, with 9% lost to follow-up.
Participants were enrolled from September 2003 to March 2004 and followed through August 2004. Women were interviewed about sociodemographic characteristics and sexual history using structured questionnaires in Xhosa and English. They were then randomized to receive a home self-sampling and self-testing kit or a clinic appointment to be screened for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV). All women had a clinic appointment 6 weeks after enrolment for clinical follow-up and interview. Up to three attempts were made to contact women who missed this visit. The home kit consisted of a paper bag containing two vaginal swabs in sealed plastic tubes (to be mailed in for polymerase chain reaction [PCR] testing for NG and CT); a XenoStrip TV test (a rapid TV dipstick test) with a small container of buffer solution; instructions on how to use the kit, with diagrams and a toll-free phone number; two self-administered questionnaires; an addressed envelope with pre-paid postage for mailing used materials and questionnaires; condoms; a pen; and educational materials on STIs and other reproductive health services. Women in the clinic group received an identical-looking paper bag containing condoms and educational materials and a clinic appointment card. At their appointment, women were given two swabs for self-sampling and the rapid TV test for self-testing. In this group, nurses observed self-sampling and self-testing and recorded any difficulties the participants displayed. Women who tested positive by rapid test at the clinic were treated that day. Women in the home group with a positive rapid TV test were asked to call the toll-free number and come to the clinic for treatment. All women were asked to call the toll-free number for their PCR results 2 weeks after specimen collection. Women with positive test results who had not previously been treated were contacted or treated at their follow-up visit and asked to choose among different partner notification methods.
The first main study outcome was the proportion of women who responded to the initiative, defined as mailing their kit or attending their clinic appointment. Women in the home group whose packages were not received but who called to report a positive rapid TV test or report having done the rapid TV test and/or mailing the package at the 6-week visit were coded as "partial responders." Second, feasibility of home and clinic self-sampling for all infections and self-testing for TV was measured in both groups by questions on difficulties performing these procedures and by clinician observation in the clinic group. Finally, acceptability was measured immediately after study procedures with self-administered questionnaires and by interview at the follow-up visit asking participants' preferences for future STI screening.
Proportion of women who responded. Forty-two percent of women in the clinic group came for their appointment, compared with 47% of the home group's mailed packages received, with an additional 14% of the home group reporting partial responses. Excluding partial responders, women in the home group were 30% more likely to respond than women in the clinic group (risk rate [RR]=1.3, 95% CI: 1.1-1.5; risk difference (RD)=11.9%; 95% CI: 3.5%-20.0%). There was no difference between the response rates of the two groups (RR=1.1; 95% CI: 0.9-1.3, RD=4.5%; 95% CI: -3.3%-12.2%) counting partial responders as non-responders. However, assuming that they were responders, the response rate was significantly higher in the home group (60%) than in the clinic group (42%; RR=1.4; 95% CI: 1.2-1.7, RD=18.2%; 95% CI: 10.5%-25.9%). Excluding partial responders, women in the home group had 1.7 (95% CI: 1.2-2.5) times the odds of responding to the initiative as women in the clinic, when age, education, recruitment site, number of sex partners in last 6 months, and reported STI history were controlled for. Older women were slightly more likely to respond than younger women (age=23-25 years vs. 14-17 years: adjusted odds ratio [AOR]=2.9; 95% CI: 1.6-5.1, age=21-22 years vs. 14-17 years: AOR=1.5; 95% CI: 0.9-2.6, age=18-20 years vs. 14-17 years: AOR=1.9; 95% CI: 1.2-3.0), as were women who had ever attended university (AOR=1.8; 95% CI: 1.1-2.9). Within the clinic group, other variables associated with responding were reporting ever having had sex (OR=2.9; 95% CI: 1.1-7.4), reporting unusual vaginal discharge at enrolment (OR=2.3; 95% CI: 1.1-4.8), and ever having had an STI symptom without seeking care (OR=2.7; 95% CI: 1.3-5.3). Within the home group, the number of lifetime sex partners was also significantly associated with responding (OR=1.2; 95% CI: 1.0-1.4).
A total of 274 (44%) women were tested by PCR: 143 (46%) in the home group and 131 (41%) in the clinic group. Overall, 22% tested positive for CT, 10% for TV, and 8% for NG. Women in the clinic group were more likely to test positive for CT than were those in the home group (27% vs. 15%, p=0.02).
Feasibility. Of the 168 women who reported mailing their kits, 146 (87%) kits were received at the clinic. Almost all (96%) contained the self-collected swab, 79% contained the used TV test strip, and 77% contained the self-administered questionnaire. Although most women reported that self-sampling was easy or very easy, more women in the clinic group reported this than women in the home group. At the 6-week interview, 65% of women in the home group reported having used the rapid TV test on their own. Ninety-five percent of these women reported being able to read the results, and 92% of the recorded results matched the reading by clinic staff. Almost all clinic women (98%) who came for their appointment found it easy or very easy to perform the rapid test on their own. In the home group, 26% reported using the toll-free number, compared with 14% in the clinic group (p=0.001).
Acceptability. Almost all (97%) women at the 6-week interview who successfully self-sampled reported that they would self-sample in the future. In choosing between self-sampling at home and at the clinic, women in the home group reported preferring the home (58%), whereas women in the clinic group reported preferring the clinic (66%). The main reasons for preferring home were privacy (42%) and ease (39%); the main reasons for preferring the clinic were being worried about making mistakes (46%), wanting supervision (25%), and not having privacy at home (21%). When choosing a location for self-testing, the majority (60%) in the home group would prefer to self-test at home, whereas most (71%) women in the clinic group would prefer the clinic. The main advantages for self-testing at home were privacy (60%) and confidentiality (36%), whereas the main advantages for self-testing at the clinic were availability of nurses to help (53%) and receiving immediate treatment (45%). Eighty-five percent of women in both groups would purchase self-sampling and self-testing kits at the pharmacy were they available. Participants would be willing to pay a median of 16 Rand (approximately US$2.30).
The authors conclude that self-sampling and self-testing are feasible and acceptable options in low-income communities such as Gugulethu. As rapid diagnostic tests become available and laboratory infrastructure improves, these methodologies should be integrated into services, especially services aimed at young women.
Quality of the study was assessed based on the following four domains: Generation of allocation sequence: adequate - use of a random sequence was prepared before study initiation. Allocation concealment: adequate - staff opened a sealed randomization envelope for the next sequential identification number containing group assignment. Blinding: impossible after randomization, as women either received a home kit or clinic appointment, and participant materials were labeled by group. Loss to follow-up: 9% were lost to follow-up by the 6-week visit (9.6% in the home group and 8.6% in the clinic group).
This study had other limitations. Women were recruited from clinics and were probably predisposed to clinic attendance, which was one of the two arms of the study. The results showed that women preferred the setting in which they had experience for self-sampling. Having women try both environments and discuss preferences may have been more informative. Finally, the choice of interpretation of "partial responders" alters study findings: excluding partial responders, women in the home group were 30% more likely to respond than women in the clinic group, whereas there was no difference between the response rates of the two groups when partial responders were counted as non-responders.
New strategies to increase coverage of STI testing, diagnosis and treatment are vitally needed to combat the persistently high rates of curable STIs globally. This need is especially pronounced in resource-poor settings such as sub-Saharan Africa, which has a high burden of disease, dependence on syndromic management for diagnosis, and low levels of health infrastructure.(1) Few studies have evaluated home sampling, and almost none have evaluated self-testing in resource-poor settings such as South Africa, where STI prevalence is high. The authors implemented a similar study concurrently in Sao Paulo, Brazil with a wider age range of women.(2) The study in Brazil also found a slightly higher response rate for home-based than clinic-based STI screening within 2 weeks of enrolment (80% vs. 76%). Both studies showed a modest effect, suggesting that home-based screening is, at a minimum, as acceptable as clinic-based screening for women in resource-poor settings, and may result in more women being screened. The authors hypothesize that the higher response rate in Brazil than in South Africa may be due to sociocultural differences, as well as to the inclusion of older women who may have fewer barriers to receiving STI screening.
Self-sampling and self-testing were feasible and acceptable in both clinic and home settings in a low-income community. However, women at home had more difficulties than women in the clinic in terms of performing the rapid test and reading the test results. As rapid diagnostics continue to be developed, instructions should be pre-tested carefully and designs should be refined for ease of interpretation of results. Women did not report difficulties using the mail and the toll-free number, suggesting that this type of screening initiative is possible in resource-poor settings. The low use of the toll-free phone number, however, suggests the need for alternate means of communication to provide test results and treatment. The study findings have limited policy implications at present in that the cost of commercial PCR diagnostics for CT and NG remains prohibitively high. Finally, the modest overall STI screening rates indicate the need for other approaches to improve screening uptake in this type of setting.
- Low N, Broutet N, Adu-Sarkodie Y, Barton P, Hossain M, Hawkes S. Global control of sexually transmitted infections. Lancet 2006 Dec 2;368(9551):2001-16.
- Lippman SA, Jones HE, Luppi CG, Pinho AA, Veras MA, van de Wijgert JH. Home-based self-sampling and self-testing for sexually transmitted infections: acceptable and feasible alternatives to provider-based screening in low-income women in Sao Paulo, Brazil. Sex Transm Dis 2007 Jul;34(7):421-8.