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Preplanned Studies: Effectiveness of Frequent Viral Load Testing Plus Additional Interventions to Prevent HIV Transmission in Heterosexual, Serodiscordant Couples — Yunnan Province, China, 2019–2021

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  • Summary

    What is already known about this topic?

    HIV transmission among serodiscordant couples remains a persistent issue in China. However, the practice of combining counseling with antiretroviral therapies (ART) to enhance ART adherence is not widely implemented or recommended in Chinese health guidelines.

    What is added by this report?

    This randomized controlled trial suggests that increased follow-up, counseling, and awareness of HIV risk can enhance ART compliance, thereby maximizing treatment efficacy.

    What are the implications for public health practice?

    Early testing and counseling of serodiscordant couples, following the identification of a human immunodeficiency virus (HIV) positive spouse, is crucial for initiating ART and reducing the risk of seroconversion in the uninfected partner. Implementing a combination of ART and adjunct counseling in China is advisable.

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  • Funding: Funding The study was supported by the National Health Commission of the People’s Republic of China (grant number 2018ZX10721102)
  • [1] Wang LY, Ding ZW, Qin QQ, Cai C, Guo W, Cui Y. Characteristics of HIV transmission through heterosexual contact in China, 2008-2014. Chin J Epidemiol 2015;12(12):1332 − 6. https://doi.org/10.3760/cma.j.issn.0254-6450.2015.12.002CrossRef
    [2] Glass T, Myer L, Lesosky M. The role of HIV viral load in mathematical models of HIV transmission and treatment: a review. BMJ Glob Health 2020;5(1):e001800. https://doi.org/10.1136/bmjgh-2019-001800CrossRef
    [3] Ministry of Health Working Group on Clinical AIDS Treatment. China free antiretroviral treatment manual. 4th ed. Beijing: People’s Medical Publishing House. 2016. https://www.docin.com/p-2355721091.html&key=%E8%89%BE%E6%BB%8B%E7%97%85%E6%80%8E%E4%B9%88%E6%B2%BB. (In Chinese). 
    [4] Mujugira A, Celum C, Coombs RW, Campbell JD, Ndase P, Ronald A, et al. HIV transmission risk persists during the first 6 months of antiretroviral therapy. J Acquir Immune Defic Syndr 2016;72(5):579 − 84. https://doi.org/10.1097/QAI.0000000000001019CrossRef
    [5] Jia ZW, Mao YR, Zhang FJ, Ruan YH, Ma Y, Li J, et al. Antiretroviral therapy to prevent HIV transmission in serodiscordant couples in China (2003-11): a national observational cohort study. Lancet 2013;382(9899):1195 − 203. https://doi.org/10.1016/S0140-6736(12)61898-4CrossRef
    [6] Baggaley RF, White RG, Hollingsworth TD, Boily MC. Heterosexual HIV-1 infectiousness and antiretroviral use: systematic review of prospective studies of discordant couples. Epidemiology 2013;24(1):110 − 21. https://doi.org/10.1097/EDE.0b013e318276cad7CrossRef
    [7] Baker Z, Gorbach P, De Melo MG, Varela I, Sprinz E, Santos B, et al. The effect of partnership presence and support on HIV viral suppression among serodiscordant partnered and single heterosexual HIV-positive individuals in Brazil. AIDS Behav 2021;25(6):1946 − 53. https://doi.org/10.1007/s10461-020-03124-5CrossRef
    [8] Wang L, Peng Z, Li M, Norris J, Wang L, Cao W, et al. HIV seroconversion and prevalence rates in heterosexual discordant couples in China: a systematic review and meta-analysis. AIDS Care, 2012;24:1059 − 70
    [9] Tang HL, Wu ZY, Mao YR, Cepeda J, Morano J. Risk factor associated with negative spouse HIV seroconversion among sero-different couples: a nested case-control retrospective survey study in 30 counties in Rural China. PLoS One 2016;11(10):e0164761. https://doi.org/10.1371/journal.pone.0164761CrossRef
    [10] Lewis SC, Warlow CP. How to spot bias and other potential problems in randomised controlled trials. J Neurol, Neurosurg Psychiatry 2004;75(2):181 − 7. https://doi.org/10.1136/jnnp.2003.025833CrossRef
  • FIGURE 1.  Viral suppression iin intervention group and standard-of-care group. (A) VL <1000 copies/mL in intervention group; (B) VL <1000 copies/mL in standard-of-care group; (C) VL <200 copies/mL in intervention group; (D) VL <200 copies/mL in standard-of-care group; (E) VL <50 copies/mL in intervention group; (F) VL <50 copies/mL in standard-of-care group.

    TABLE 1.  Baseline characteristics of participants in the intervention and control groups.

    Variables Control group participants, N (%) Intervention group participants, N (%) P value*
    Overall 371 (100.0) 372 (100.0)
    Age, years
    18–39 132 (35.6) 163 (43.8) 0.022
    40–59 239 (64.4) 209 (56.2)
    Sex
    Male 250 (67.4) 266 (71.5) 0.223
    Female 121 (32.6) 106 (28.5)
    Education
    Illiterate 47 (12.7) 54 (14.5) 0.598
    Primary school 175 (47.2) 176 (47.3)
    Junior high school 107 (28.8) 110 (29.6)
    ≥Senior high school 42 (11.3) 32 (8.6)
    Occupation
    Farmer 299 (80.6) 311 (83.6) 0.301
    Labourer 31 (8.4) 34 (9.1)
    Homemaker/unemployed 26 (7.0) 15 (4.0)
    Others 15 (4.0) 12 (3.2)
    CD4+ T cell count at diagnosis
    ≤200 113 (31.1) 119 (32.8) 0.703
    201–499 200 (55.1) 189 (52.1)
    ≥500 50 (13.8) 55 (15.2)
    Sexual behavior in the past month
    Had sexual behavior
    No 94 (25.3) 67 (18.0) 0.015
    Yes 277 (74.7) 305 (82.0)
    Frequency of sexual behaviors
    ≤3 162 (58.5) 166 (54.4) 0.324
    ≥4 115 (41.5) 139 (45.6)
    Frequency of condom use
    Every time 50 (12.5) 24 (8.7) 0.516
    Sometimes 131 (32.7) 68 (24.5)
    Never 401 (68.9) 185 (66.8)
    * Categorical variables and continuous variables were compared between the intervention group and the control group using the Chi-square test and T-test, respectively.
    Download: CSV

    TABLE 2.  Follow-up characteristics of participants in the intervention and control groups.

    Variables Control group participants,
    N (%)/median (IQR)
    Intervention group participants
    N (%)/median (IQR)
    P value*
    Overall, N (%) 371 (100.0) 372 (100.0)
    Seroconversion
    N/100PY 3/486.7 (0) 0/470.8 (0.6) 0.081
    Observation time, person-month
    Median (IQR) 15.8 (10.6–20.5) 15.3 (10.8–18.8) 0.227
    Days from diagnosis to spouse test
    Median (IQR) 0 (0–4) 0 (0–3) 0.376
    Days from diagnosis to ART initiation
    Median (IQR) 6 (2–18) 5 (2–9) <0.001
    Frequency of viral load test
    Median (IQR) 2 (2–3) 7 (5–8) <0.001
    Initiated ART within 7 days from diagnosis, N (%)
    No 150 (40.4) 117 (31.5) 0.011
    Yes 221 (59.6) 255 (68.5)
    Initiated ART within 14 days from diagnosis, N (%)
    No 106 (28.6) 54 (14.5) <0.001
    Yes 265 (71.4) 318 (85.5)
    Sexual behavior in the past month at last recorded follow-up
    Had sexual behavior
    No 129 (34.8) 119 (31.9) 0.421
    Yes 242 (65.2) 253 (68.0)
    Frequency of sexual behaviors
    ≤3 157 (64.9) 161 (63.6) 0.774
    ≥4 85 (35.1) 92 (36.4)
    Frequency of condom use during sexual activity
    Sometimes/never 19 (7.9) 10 (4.0) 0.065
    Every time 223 (92.1) 243 (96.0)
    Within 3 months after diagnosis
    Viral load test, N (%)
    No 174 (46.9) 3 (0.8) <0.001
    Yes 197 (53.1) 369 (99.2)
    Viral load <1,000 copies/L, N (%)
    No 86 (43.7) 51 (13.8) <0.001
    Yes 111 (56.3) 318 (86.2)
    Viral load <200 copies/L, N (%)
    No 112 (56.9) 131 (35.5) <0.001
    Yes 85 (43.1) 238 (64.5)
    Viral load <50 copies/L, N (%)
    No 144 (73.1) 239 (64.8) 0.044
    Yes 53 (26.9) 130 (35.2)
    Within 4 months after diagnosis
    Viral load test, N (%)
    No 62 (16.7) 0 (0) <0.001
    Yes 309 (83.3) 372 (100.0)
    Viral load <1,000 copies/L, N (%)
    No 53 (17.2) 30 (8.1) 0.001
    Yes 256 (82.8) 342 (91.9)
    Viral load <200 copies/L, N (%)
    No 102 (33.0) 92 (24.7) 0.017
    Yes 207 (67.0) 280 (75.3)
    Viral load <50 copies/L, N (%)
    No 169 (54.7) 190 (51.1) 0.347
    Yes 140 (45.3) 182 (48.9)
    Viral load at last recorded follow-up
    Viral load test, N (%)
    No 8 (2.2) 0 (0) 0.004
    Yes 363 (97.8) 372 (100.0)
    Viral load <1,000 copies/L, N (%)
    No 22 (6.1) 8 (2.2) 0.007
    Yes 341 (93.9) 364 (97.8)
    Viral load <200 copies/L, N (%)
    No 40 (11.0) 21 (5.6) 0.008
    Yes 323 (89.0) 351 (94.4)
    Viral load <50 copies/L, N (%)
    No 66 (18.2) 37 (9.9) 0.001
    Yes 297 (81.8) 335 (90.1)
    Abbreviation: IQR=inter-quartile range.
    * Categorical variables and continuous variables were compared between the intervention group and the control group using the Chi-square test and T-test, respectively.
    Download: CSV

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Effectiveness of Frequent Viral Load Testing Plus Additional Interventions to Prevent HIV Transmission in Heterosexual, Serodiscordant Couples — Yunnan Province, China, 2019–2021

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Summary

What is already known about this topic?

HIV transmission among serodiscordant couples remains a persistent issue in China. However, the practice of combining counseling with antiretroviral therapies (ART) to enhance ART adherence is not widely implemented or recommended in Chinese health guidelines.

What is added by this report?

This randomized controlled trial suggests that increased follow-up, counseling, and awareness of HIV risk can enhance ART compliance, thereby maximizing treatment efficacy.

What are the implications for public health practice?

Early testing and counseling of serodiscordant couples, following the identification of a human immunodeficiency virus (HIV) positive spouse, is crucial for initiating ART and reducing the risk of seroconversion in the uninfected partner. Implementing a combination of ART and adjunct counseling in China is advisable.

  • 1. National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
  • 2. Yunnan Provincial Center for Disease Control and Prevention, Kunming City, Yunnan Province, China
  • 3. Honghe Prefectural Center for Disease Control and Prevention, Honghe City, Yunnan Province, China
  • 4. Wenshan Prefectural Center for Disease Control and Prevention, Wenshan City, Yunnan Province, China
  • 5. Zhaotong Prefectural Center for Disease Control and Prevention, Zhaotong City, Yunnan Province, China
  • 6. Lincang Prefectural Center for Disease Control and Prevention, Lincang City, Yunnan Province, China
  • 7. Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia
  • Corresponding author:

    Yufen Liu, yufenliu69@chinaaids.cn

  • Funding: Funding The study was supported by the National Health Commission of the People’s Republic of China (grant number 2018ZX10721102)
  • Online Date: July 05 2024
    Issue Date: July 05 2024
    doi: 10.46234/ccdcw2024.122
  • Approximately two-thirds of newly reported human immunodeficiency virus (HIV) infections in China originate from heterosexual contacts, with one-tenth stemming from a spouse or regular partner (1). It is thus crucial to manage transmission within serodiscordant couples to diminish the incidence of new infections. Although the World Health Organization (WHO) underlines the importance of regular viral load monitoring during the early stages of antiretroviral therapies (ART) (2), Chinese clinical guidelines currently advise conducting such tests only after six months of ART (3). In this study, we enrolled newly diagnosed HIV-1 serodiscordant couples from 15 health centers in Yunnan Province, assigning half to an enhanced prevention strategy. This strategy included a comprehensive reproductive plan, joint spouse testing and consultation, early treatment, frequent viral load monitoring, fertility advice, and ART. The remaining participants received ART alongside the standard care per Chinese guidelines. The enhanced strategy led to a significantly higher number of participants in the intervention group initiating ART within 7 and 14 days of diagnosis compared to the control group. Additionally, the intervention group showed significantly higher rates of viral suppression. None of the spouses in the intervention group were seroconverted (0/100 person-years), while three were in the control group (0.6/100 person-years). These findings support the notion that increased viral load testing frequency and comprehensive counseling can improve treatment outcomes and reduce HIV transmission among serodiscordant couples.

    This randomized controlled trial (RCT) recruited HIV-1 serodiscordant couples, all participants being over 18 years of age, from 15 centers in Yunnan Province, China. Inclusion criteria were as follows: the HIV-positive partner was diagnosed during the study period (February 15, 2019 to March 31, 2021); their spouse was confirmed HIV-negative at baseline and maintained this status for three months subsequent to their partner’s diagnosis; both partners were aged between 18 and 59 years; the couples consented to participate in the study willingly and were able to provide informed consent; and the couple had engaged in sexual activity at least once in the preceding year. (Data and Sample Collection and HIV-1 Testing refer to the Supplementary Material)

    Trained health professionals monitored newly reported positive cases. Couples who met the inclusion criteria were randomly assigned in a 1:1 ratio to either the intervention group or the standard-of-care group using sequential random grouping.

    In the intervention group, health professionals assessed HIV-positive individuals at an outpatient facility, providing treatment consultations and pre-treatment physical examinations. These individuals began ART within one week and underwent viral load testing at 1, 2, 3, 9, 12, and 18 months post-diagnosis. Health professionals also encouraged the HIV-positive patients to disclose their status to their spouses within a week. Couples received counseling on condom usage, HIV care, treatment adherence, reproductive intentions, and safe pregnancy methods. Those planning to conceive were referred to maternal and child health services for expert fertility advice and strategies to prevent perinatal transmission. Viral load results were shared with both partners. The HIV-negative partners underwent testing for HIV seroconversion at 3, 12, 18, and 24 months after the initial HIV diagnosis of their spouses.

    In the standard-of-care group, health professionals initiated contact with the treatment facility to commence ART for HIV-positive partners. These partners underwent viral load testing at 3 and 6 months post-diagnosis for comparative analysis with the intervention group. The HIV-negative spouses received testing for HIV seroconversion 3 months after their partners’ diagnosis and again at the study’s conclusion.

    Cox regression was used to estimate relative risks, which were expressed as hazard ratios with 95% confidence intervals (CI). A P value of less than 0.05 was considered statistically significant. Kaplan-Meier estimates were employed to compare cumulative probabilities of seroconversion between participants in the intervention and control groups. All analyses were conducted using SPSS software (version 24.0, IBM, NewYork, USA).

    A total of 2,213 HIV-positive individuals, who either were married or in a committed relationship and aged 18–59, were identified between February 15, 2019, and March 31, 2021, across 15 counties in Yunnan province, China (Figure 1). Of these, 1,470 couples were excluded due to not being serodiscordant or unreachable (n=1,469), or because one partner died within 3 months of diagnosis (n=1). By the close of enrollment on March 31, 2021, 743 couples remained, with 372 assigned to the intervention group and 371 to the control group (Figure 1). Within the intervention group, six couples withdrew due to divorce. In the control group, adverse outcomes included seroconversion in three couples and withdrawals due to divorce (three couples), death of the HIV-positive spouse (three couples), and one couple’s decision to cease participation. The duration of observation for those who withdrew did not significantly differ between the groups (P=0.808). (Eligibility flow diagram for HIV serodiscordant couples refer to Supplementary Figure S1)

    Figure 1. 

    Viral suppression iin intervention group and standard-of-care group. (A) VL <1000 copies/mL in intervention group; (B) VL <1000 copies/mL in standard-of-care group; (C) VL <200 copies/mL in intervention group; (D) VL <200 copies/mL in standard-of-care group; (E) VL <50 copies/mL in intervention group; (F) VL <50 copies/mL in standard-of-care group.

    At enrollment, the majority of participants were male farmers with primary school education. The age of the HIV-positive spouse differed significantly between groups, although other demographic characteristics did not (Table 1). The median observation period was 15.3 (10.8–18.8) person-months for the intervention group and 15.8 (10.6–20.5) person-months per couple for the control group. Significantly more participants in the intervention group initiated ART within 7 and 14 days from diagnosis (P=0.011 and P<0.001, respectively). The median time from diagnosis to initiating ART was 5 days [inter-quartile range (IQR): 2–9] in the intervention group and 6 days (IQR: 2–18) in the control group (Table 2). Rates of achieving a viral load of <1,000 copies/L and <200 copies/L within 3 and 4 months of diagnosis were significantly higher in the intervention group (86.2% and 64.5%; 91.9%, and 75.3%, respectively) compared to the control group (56.3% and 43.1%; 82.8%, and 67.0%). Among those who underwent viral load testing, rates of obtaining viral loads of <1,000 copies/L, <200 copies/L, and <50 copies/L were significantly higher in the intervention group (97.8%, 94.4%, and 90.1%, respectively) compared to the control group (93.9%, 89.0%, and 81.8%) (P<0.05) (Figure 1).

    Variables Control group participants, N (%) Intervention group participants, N (%) P value*
    Overall 371 (100.0) 372 (100.0)
    Age, years
    18–39 132 (35.6) 163 (43.8) 0.022
    40–59 239 (64.4) 209 (56.2)
    Sex
    Male 250 (67.4) 266 (71.5) 0.223
    Female 121 (32.6) 106 (28.5)
    Education
    Illiterate 47 (12.7) 54 (14.5) 0.598
    Primary school 175 (47.2) 176 (47.3)
    Junior high school 107 (28.8) 110 (29.6)
    ≥Senior high school 42 (11.3) 32 (8.6)
    Occupation
    Farmer 299 (80.6) 311 (83.6) 0.301
    Labourer 31 (8.4) 34 (9.1)
    Homemaker/unemployed 26 (7.0) 15 (4.0)
    Others 15 (4.0) 12 (3.2)
    CD4+ T cell count at diagnosis
    ≤200 113 (31.1) 119 (32.8) 0.703
    201–499 200 (55.1) 189 (52.1)
    ≥500 50 (13.8) 55 (15.2)
    Sexual behavior in the past month
    Had sexual behavior
    No 94 (25.3) 67 (18.0) 0.015
    Yes 277 (74.7) 305 (82.0)
    Frequency of sexual behaviors
    ≤3 162 (58.5) 166 (54.4) 0.324
    ≥4 115 (41.5) 139 (45.6)
    Frequency of condom use
    Every time 50 (12.5) 24 (8.7) 0.516
    Sometimes 131 (32.7) 68 (24.5)
    Never 401 (68.9) 185 (66.8)
    * Categorical variables and continuous variables were compared between the intervention group and the control group using the Chi-square test and T-test, respectively.

    Table 1.  Baseline characteristics of participants in the intervention and control groups.

    Variables Control group participants,
    N (%)/median (IQR)
    Intervention group participants
    N (%)/median (IQR)
    P value*
    Overall, N (%) 371 (100.0) 372 (100.0)
    Seroconversion
    N/100PY 3/486.7 (0) 0/470.8 (0.6) 0.081
    Observation time, person-month
    Median (IQR) 15.8 (10.6–20.5) 15.3 (10.8–18.8) 0.227
    Days from diagnosis to spouse test
    Median (IQR) 0 (0–4) 0 (0–3) 0.376
    Days from diagnosis to ART initiation
    Median (IQR) 6 (2–18) 5 (2–9) <0.001
    Frequency of viral load test
    Median (IQR) 2 (2–3) 7 (5–8) <0.001
    Initiated ART within 7 days from diagnosis, N (%)
    No 150 (40.4) 117 (31.5) 0.011
    Yes 221 (59.6) 255 (68.5)
    Initiated ART within 14 days from diagnosis, N (%)
    No 106 (28.6) 54 (14.5) <0.001
    Yes 265 (71.4) 318 (85.5)
    Sexual behavior in the past month at last recorded follow-up
    Had sexual behavior
    No 129 (34.8) 119 (31.9) 0.421
    Yes 242 (65.2) 253 (68.0)
    Frequency of sexual behaviors
    ≤3 157 (64.9) 161 (63.6) 0.774
    ≥4 85 (35.1) 92 (36.4)
    Frequency of condom use during sexual activity
    Sometimes/never 19 (7.9) 10 (4.0) 0.065
    Every time 223 (92.1) 243 (96.0)
    Within 3 months after diagnosis
    Viral load test, N (%)
    No 174 (46.9) 3 (0.8) <0.001
    Yes 197 (53.1) 369 (99.2)
    Viral load <1,000 copies/L, N (%)
    No 86 (43.7) 51 (13.8) <0.001
    Yes 111 (56.3) 318 (86.2)
    Viral load <200 copies/L, N (%)
    No 112 (56.9) 131 (35.5) <0.001
    Yes 85 (43.1) 238 (64.5)
    Viral load <50 copies/L, N (%)
    No 144 (73.1) 239 (64.8) 0.044
    Yes 53 (26.9) 130 (35.2)
    Within 4 months after diagnosis
    Viral load test, N (%)
    No 62 (16.7) 0 (0) <0.001
    Yes 309 (83.3) 372 (100.0)
    Viral load <1,000 copies/L, N (%)
    No 53 (17.2) 30 (8.1) 0.001
    Yes 256 (82.8) 342 (91.9)
    Viral load <200 copies/L, N (%)
    No 102 (33.0) 92 (24.7) 0.017
    Yes 207 (67.0) 280 (75.3)
    Viral load <50 copies/L, N (%)
    No 169 (54.7) 190 (51.1) 0.347
    Yes 140 (45.3) 182 (48.9)
    Viral load at last recorded follow-up
    Viral load test, N (%)
    No 8 (2.2) 0 (0) 0.004
    Yes 363 (97.8) 372 (100.0)
    Viral load <1,000 copies/L, N (%)
    No 22 (6.1) 8 (2.2) 0.007
    Yes 341 (93.9) 364 (97.8)
    Viral load <200 copies/L, N (%)
    No 40 (11.0) 21 (5.6) 0.008
    Yes 323 (89.0) 351 (94.4)
    Viral load <50 copies/L, N (%)
    No 66 (18.2) 37 (9.9) 0.001
    Yes 297 (81.8) 335 (90.1)
    Abbreviation: IQR=inter-quartile range.
    * Categorical variables and continuous variables were compared between the intervention group and the control group using the Chi-square test and T-test, respectively.

    Table 2.  Follow-up characteristics of participants in the intervention and control groups.

    Among HIV-negative spouses at baseline, the seroconversion rates were 0.6 per 100 person-years (3/371) in the control group and 0 per 100 person-years in the intervention group (P=0.081). (Assessment of Linkage of Seroconversions and Analysis of seroconversion case sequences refer to Supplementary Figures S2–S3)

    Characteristics of the seroconverted spouses are summarized. (Characteristics of the three seroconverted couples refer to the Supplementary Table S1) The time intervals from the diagnosis of HIV-positive status to spouse seroconversion were 117, 121, and 182 days, respectively. Phylogenetic analysis confirmed that all seroconversion cases were linked to their HIV-positive partners (refer to Supplementary Figure S2).

    • After 18 months, seroconversion was observed in three couples from the standard-of-care group, whereas no seroconversions occurred in the intervention group; however, this difference was not statistically significant. Nevertheless, the reduced viral load titers observed in the intervention group suggest that integrating ART with viral load monitoring and non-medical preventative strategies may enhance ART adherence and reduce the likelihood of HIV transmission between spouses.

      All three spouses seroconverted within 6 months of initiating ART, aligning with previous findings that this period represents the highest risk for serodiscordant couples starting ART (4). This increased vulnerability is attributed to the initial inability of ART to sufficiently suppress viral load, coupled with the persistence of unprotected sexual activities that may facilitate HIV transmission between spouses (5-6). Consequently, enhancing provider-patient communication regarding the high likelihood of seroconversion during the initial six months of ART and emphasizing the necessity of adherence could serve as crucial strategies. These measures are essential not only for educating on safer sexual practices but also for achieving viral suppression as swiftly as possible (7).

      Although no statistical differences were identified between groups, seroconversion rates were notably lower compared to similar populations documented in other Chinese studies from Yunnan (8-9). For the intervention groups, the low incidence of seroconversion could be attributed to stringent testing and counseling. However, the awareness associated with enrolling in an unblinded RCT might introduce selection bias and increase motivation among both groups to engage in health-promoting behaviors (10).

      Although this study offers insights into the impact of supplementary preventative strategies on HIV seroconversion, several limitations must be acknowledged. Given the non-blinded nature of this study, participants in the standard-of-care group were aware that they were not receiving additional interventions. This awareness may have engendered feelings of disadvantage, potentially prompting more cautious behaviors that could reduce seroconversion rates and introduce bias; however, this effect is presumed to be minimal. The absence of statistical significance between groups suggests that both intensive and non-intensive preventative strategies are effective, provided that ART is recommended and adhered to. Nevertheless, the sample size and follow-up durations were suboptimal compared to other studies, implying a need for optimization to confidently and safely conclude that extensive viral load monitoring and additional preventative measures do not further reduce the risk of seroconversion. Additionally, the study’s restriction to a single province in China might limit its generalizability to other regions with different cultural and demographic profiles, which could affect adherence to and acceptance of HIV and ART protocols. Despite a solid foundation in HIV/Acquired Immune Deficiency Syndrome (AIDS) prevention and control efforts in Yunnan Province, the lack of interventions in the control group might still influence the outcomes due to overarching prevention activities. Future studies that employ blinding, larger cohorts, and extended follow-up durations may yield more definitive conclusions on whether the standard-of-care guidelines in China are as effective as multiple intervention strategies.

    • The protocol was reviewed approved by the Institutional Review Board of National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention (Project No: X190111538) and was registered on Chinese Clinical Trail Register (RegistrationNo: ChiCTR1900021192). All participants signed informed consent before enrolling in the study.

    • No conflicts of interest.

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