Abrahams 2010.

Methods	Randomized controlled trial
Participants	The study location was Sinawe sexual assault service, Mthatha, South Africa, and Karl Bremer Hospital, Victoria Hospital, and the Simelela Centre; all in Khayelitsha, South Africa 136 participants were randomized to the intervention group and 138 participants were randomized to the control group The inclusion criteria were women and girl children; girls under 16 years of age were eligible if accompanied by a care giver The exclusion criteria were rape victims who did not get post‐exposure prophylaxis (PEP) (due to being HIV positive or because they did not take an HIV test), those unable to give consent for reason of severe injury or severe mental distress (including severely distressed guardians), and those who were not contactable telephonically
Interventions	Intervention: TELEPHONE COUNSELING Patients in the intervention group received standard care and telephone counseling sessions. The telephone counseling included 4 calls in the first week, 3 calls in the 2nd and 3rd week, and 2 calls in the last week, but more were made if necessary. The support included the application of basic counseling skills including listening and validating the traumatic events, encouraging participants to take their medication, to seek support from family and friends, to attend formal counseling services, to read the pamphlet, use the diary, and return to the clinic for follow‐up medication Control: STANDARD CARE Standard care consisted of psychological containment, medical examination, and collection of forensic evidence; HIV testing with pre‐ and post‐test counseling; providing emergency contraception, treatment of sexually transmitted infections and PEP for HIV. Follow‐up was arranged to collect further HIV PEP medication. All patients had an interactive information session to explain the content of the pamphlet, answer questions, and demonstrate initiation of the use of the medication diary. The pamphlet contained specific information about taking PEP after a sexual assault; a diary for the 28‐day period on which pill taking was to be marked and contact information on support services. No further contact was made with participants in the control group until the final interview, but they continued to receive standard care from the service
Outcomes	The measures of adherence were assessed within 5 days of the 28‐day treatment period ending in a face to face interview conducted by a fieldworker. Non‐adherence was defined as missing 3 or more doses of medication (of 56 doses). Patients who did not return to the facility to collect the full 28 days of medication, or who were found to have more than 3 doses remaining when pills were counted/volume of syrup was assessed, were considered non‐adherent. If medication containers were not available at the interview, participants were asked to estimate the number of pills or volume of syrup remaining The patient outcomes were depressive symptomatology, measured by the Centre for Epidemiological Studies Depression Scale, measured 4 weeks after the beginning of treatment (within 4 days of treatment ending). The scale was administered by a fieldworker
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A computer‐generated randomization list was generated by the study statistician and random block sizes of 4, 6 and 8 were used to ensure balance in the 2 arms (pg 1176)
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not specified; (pg 1176) a computer‐generated randomization list was generated by the study statistician and random block sizes of 4, 6 and 8 were used to ensure balance in the 2 arms. Participants were allocated to an arm by the study co‐ordinator after the initial data had been collected and leaflet explained
Selective reporting (reporting bias)	Unclear risk	No protocol available, therefore unable to determine if everything was reported
Other bias	Unclear risk	There appears to be weaknesses in the intervention delivery such as variations in the number of telephone calls, which may have attenuated the differences between the intervention and the control group
Blinding of outcome assessment (detection bias) Adherence measure	Unclear risk	(PRIMARY) PILL COUNT/SYRUP MEASURE ‐ fieldworkers who did the final interview were blinded to study arm, but this may have been disclosed by the participants during the final interviews. Participants could not be blinded to the study arm(pg 1176)
Blinding of outcome assessment (detection bias) Patient outcome	Unclear risk	(PRIMARY) DEPRESSIVE SYMPTOMOLOGY ‐ fieldworkers were blind to condition but blinding could have been broken by the patients (pg 1176)
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) PILL COUNT/SYRUP MEASURE ‐ participants could not be blinded to the study arm
Blinding of participants (performance bias) Patient outcome	Unclear risk	(PRIMARY) DEPRESSIVE SYMPTOMOLOGY ‐ patients could not be blinded (pg 1176), but unclear if this might have affected their responses to the scale
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) PILL COUNT/SYRUP MEASURE ‐ outcome unlikely to be affected if other personnel were not blinded
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) DEPRESSIVE SYMPTOMOLOGY ‐ not specified, but other personnel are unlikely to have influenced the data collection
Incomplete outcome data (attrition bias) Adherence measure	Unclear risk	(PRIMARY) PILL COUNT/SYRUP MEASURE ‐ not enough detail given on reasons for loss to follow‐up. Number is small and balanced across groups but still unclear what impact this would have
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) DEPRESSIVE SYMPTOMOLOGY ‐ not enough detail given on reasons for loss to follow‐up. Number is small and balanced across groups but still unclear what impact this would have